FDA 510(k) Applications for Medical Device Product Code "JLW"
(Radioimmunoassay, Thyroid-Stimulating Hormone)

FDA 510(k) Number Applicant Device Name Decision Date
K983442 ABBOTT LABORATORIES ABBOTT ARCHITECT TSH 11/20/1998
K981060 ABBOTT LABORATORIES ABBOTT AXSYM 3RD GENERATION TSH ASSAY 04/29/1998
K843540 ABBOTT LABORATORIES ABBOTT HTSH EIA DIAGNOSTIC KIT 11/02/1984
K880086 ABBOTT LABORATORIES ABBOTT IMX HTSH 04/05/1988
K934410 ABBOTT LABORATORIES AXSYM ULTRASENSITIVE HTSH 06/21/1994
K952148 ABBOTT LABORATORIES AXSYM ULTRASENSITIVE HTSH II 06/29/1995
K822827 ABBOTT LABORATORIES HISH EIA DIAGNOSTIC KIT 10/27/1982
K791747 ABBOTT LABORATORIES HTSH NEONATE RIA DIAGNOSTIC KIT 11/13/1979
K771235 ABBOTT LABORATORIES HTSH RIA HUMAN THYROID HORMONE RIA 08/03/1977
K942566 ABBOTT LABORATORIES IMX ULTRASENSISTIVE HTSH II 08/16/1994
K902753 ABBOTT MFG., INC. IMX ULTRASENTITIVE HTSH 07/10/1990
K980574 ALFA BIOTECH (UK) LTD. AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0 03/24/1998
K862428 AMERICAN DADE STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY 08/19/1986
K802467 AMERICAN DIAGNOSTIC CORP. TSH RADIOIMMUNOASSAY KIT 10/31/1980
K812136 AMERSHAM CORP. AMERLEX TSH RIA KIT 08/13/1981
K842948 AMERSHAM CORP. AMERLEX-M TSH RIA 09/04/1984
K882907 AMERSHAM CORP. AMERLITE TSH ASSAY, LAN.0001/2001 240 & 144 KIT 09/22/1988
K904666 AMERSHAM CORP. AMERLITE TSH-60 ASSAY PRODUCT CODE: LAN. 0008/2008 11/02/1990
K780726 AMERSHAM CORP. TSH RIA KIT 06/13/1978
K791217 ANTIBODIES INC. TSH RIA KIT 09/04/1979
K013420 AWARENESS TECHNOLOGY, INC. CHEMWELL, ALSO KNOWN AS PROJECT 2900 07/19/2002
K912241 BAXTER HEALTHCARE CORP. STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY 06/20/1991
K912852 BAXTER HEALTHCARE CORP. STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO 09/27/1991
K981312 BAYER CORP. 3RD GENERATION TSH ASSAY FOR THE BAYER IMMUNO 1 SYSTEM 06/05/1998
K865081 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC AFFINITY(TM) HTSH IMMUNIT(TM) 03/12/1987
K897138 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC AFFINITY(TM) HTSH(TM) 03/09/1990
K841606 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC BLOOD SPOT NEONATAL TSH RADIOIMMUNO 05/22/1984
K800798 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC HUMAN THYROID STIM. HORMONE/ARIA II 04/24/1980
K870244 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC IQ TSH IMMUNOASSAY 04/01/1987
K760044 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC KIT, RIA, HUMAN THYROID HORMONE 07/26/1976
K912324 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY 06/20/1991
K861920 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. 06/16/1986
K864839 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC TSH MAB IRMA 02/04/1987
K023093 BECKMAN COULTER, INC. ACCESS HYPERSENSITIVE HTSH ASSAY 11/25/2002
K153651 BECKMAN COULTER, INC. Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems 08/18/2016
K042281 BECKMAN COULTER, INC. MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY 09/16/2004
K831972 BECKMAN INSTRUMENTS, INC. EPSILON TSH TEST KIT 09/20/1983
K925132 BECTON DICKINSON ADVANCED DIAGNOSTICS BECTON DICKINSON THYROID STIMULATING HORMONE SYSTE 12/28/1992
K873303 BINAX, INC. BINAX L.S. TSH IRMA TEST KIT 10/02/1987
K921958 BIO CLINIC CO. ELISA TUBE TSH TEST 07/02/1992
K864659 BIO MEGA DIAGNOSTIC, INC. BIO-MEGA DIAGNOSTIC COATED TUBE IRMA TSH 02/04/1987
K930006 BIO-CHEM LABORATORY SYSTEMS, INC. AUTOBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT 09/09/1993
K890802 BIO-RAD COTUBE(TM) TSH IRMA 03/28/1989
K860288 BIO-RAD ECHOCLONAL HTSH IRMA 04/11/1986
K903311 BIO-RAD NOVAPATH TSH ENZYME IMMUNOASSAY 09/07/1990
K822291 BIO-RAD QUANTIMUNE HTSH IRMA 08/27/1982
K781170 BIO-RAD QUANTIMUNE HTSH IRMA HUMAN THYROID 08/14/1978
K935119 BIO-RAD RADIAS 3RD GENERATION TSH IMMUNOASSAY 04/06/1994
K935399 BIO-RAD RADIAS NEONATAL TSH ENZYME IMMUNOASSAY 12/19/1994
K931061 BIO-RAD RADIAS TSH ENZYME IMMUNOASSAY 06/16/1993
K760132 BIO-RAD TEST, RIA, TSH QUANTIMUNE 07/20/1976
K925637 BIO-RAD LABORATORIES, INC. ACCESS HTSH ASSAY 03/01/1993
K954825 BIO-RAD LABORATORIES, INC. ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER 11/21/1995
K990993 BIOCHECK, INC. BIOCHECK SENSITIVE TSH (S-TSH) ENZYME IMMUNOASSAY TEST KIT; CATALOG NUMBER: BC-1003 06/22/1999
K991146 BIOCHECK, INC. TSH ENZYME IMMUNOASSAY TEST KIT, MODEL #BC-1001 06/22/1999
K961566 BIOCIRCUITS CORP. BIOCIRCUITS IOS TSH TEST CARTRIDGES/THYROID CONTROLS 11/18/1996
K854379 BIOCLINICAL SYSTEMS, INC. MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT 01/07/1986
K935049 BIOCLONE AUSTRALIA PTY LTD. ELEGANCE NEONATAL TSH ELISA 10/03/1994
K905099 BIOCLONE AUSTRALIA PTY LTD. ELEGANCE TSH ELISA 12/18/1990
K840088 BIODAN MEDICAL SYSTEMS, LTD. BIODEX ACT-O-KIT TSH-RIA- 05/07/1984
K962216 BIOMERICA, INC. TSH (MICROWELL) ELISA 09/19/1996
K921816 BIOMERIEUX VITEK, INC. VITEK IMMUN ASSAY SYS(VIDAS) THYROI STIM HOR ASSAY 06/18/1992
K003752 BIOSAFE LABORATORIES, INC. BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) 03/23/2001
K011525 BIOSAFE LABORATORIES, INC. SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) 07/16/2001
K833193 BIOSAN LABORATORIES, INC. RADIOIMMUNOASSAY, THYROID STIMU. HORMONE 02/04/1984
K910256 BIOTOPE, INC. ECLIPSE ICA TSH 02/22/1991
K170232 BODITECH MED INC. AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB Analyzer 10/13/2017
K961491 BOEHRINGER MANNHEIM CORP. ELECSYS TSH ASSAY 07/22/1996
K900277 BOEHRINGER MANNHEIM CORP. ENZYMUN TEST(R) TSH-S 04/11/1990
K915195 BOEHRINGER MANNHEIM CORP. ENZYMUN-TEST TSH 02/14/1992
K842593 BOOTS-CELLTECH DIAGNOSTICS, INC. SUCROSEP THYROID STIMULATING HORMONE 09/12/1984
K810213 BURROUGHS WELLCOME CO. DAC-CEL TSH 02/10/1981
K951796 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY 06/13/1995
K910981 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS TSH IMMUNOASSAY 04/30/1991
K862407 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE TSH IMMUNOASSAY 08/29/1986
K912583 CIBA CORNING DIAGNOSTICS CORP. MAGIC LITE TSH (HS) IMMUNOASSAY 08/12/1991
K905769 CIRRUS DIAGNOSTICS, INC. IMMULITE HS-TSH 01/31/1991
K860824 CIS-US, INC. TSHK-NN RIA KIT 04/28/1986
K772109 CLINICAL ASSAYS, INC. IN VITRO HUMAN TSH RIA TEST 12/06/1977
K823688 CORNING MEDICAL & SCIENTIFIC DOUBLE ANTIBODY TSH I-125 RADIOIMMUNO 01/05/1983
K781409 CORNING MEDICAL & SCIENTIFIC IMMO PHASE, THYROID HORMONE 09/27/1978
K851329 CORNING MEDICAL & SCIENTIFIC MAGIC MONOCLONAL ANTIBODY TSH(MAB TSH)RADIOIMMUNOA 06/13/1985
K832313 CORNING MEDICAL & SCIENTIFIC MAGIC TSH 125I RADIOIMMUNOASSAY 09/01/1983
K830036 CORNING MEDICAL & SCIENTIFIC NEONATAL NTSH RADIOIMMUNOASSAY SYS 01/28/1983
K781953 CORNING MEDICAL & SCIENTIFIC RIA KIT, IMMO PHASE 02/01/1979
K760255 CORNING MEDICAL & SCIENTIFIC TEST SYSTEM, THYROID STIM. HORMONE ASSAY 11/19/1976
K895396 CYBERFLUOR, INC. CYBERFLUOR FIAGEN TSH 10/31/1989
K874622 CYBERFLUOR, INC. FIAGEN(TM) HTSH CATALOGUE NUMBER: 101-301 12/18/1987
K870320 DACOMED CORP. DACOMED PENILE PROSTHESIS SIZER 03/17/1987
K060090 DADE BEHRING, INC. DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE 02/27/2006
K970393 DADE CHEMISTRY SYSTEMS, INC. THYROID STIMULATING HORMONE METHOD 03/03/1997
K792443 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. TSH RADIOIMMUNOASSAY 12/27/1979
K781150 DIAGNOSTIC CORP. OF AMERICA RIA TSH IN HUMAN SERUM OR PLASMA 07/27/1978
K943195 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT NEONATAL TSH IRMA 03/13/1995
K933212 DIAGNOSTIC PRODUCTS CORP. IMMULITE RAPID TSH 12/19/1994
K940006 DIAGNOSTIC PRODUCTS CORP. IMMULITE THIRD GENERATION (MODIFICATION) 12/19/1994
K872305 DIAGNOSTIC PRODUCTS CORP. IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX 07/01/1987
K900014 DIAGNOSTIC PRODUCTS CORP. MILENIA (TM) TSH 01/19/1990
K772192 DIAGNOSTIC PRODUCTS CORP. NEONATAL TSH RIA KIT (125I) 01/12/1978
K760801 DIAGNOSTIC PRODUCTS CORP. TSH RIA KIT 11/01/1976
K860054 DIAGNOSTIC PRODUCTS CORP. TSH-IRMA COAT-A-COUNT KIT 03/17/1986
K864134 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL-4800 ACTIVE TM TSH EIA SYSTEM 12/16/1986
K864133 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL-5300 TSH IMMUNORADIOMETRIC ASSAY (IRMA) KIT 12/18/1986
K890579 DIAMEDIX CORP. TSH MICROASSAY 03/16/1989
K130469 DIASORIN, INC. LIAISON TSH, LIAISON CONTROL THYROID 1, LIAISON CONTROL THYROID 2, LIAISON CONTROL THYROID 3 04/05/2013
K041014 DIASORIN, INC. TSH-CTK-3 IRMA 07/14/2004
K941146 DUPONT MEDICAL PRODUCTS DUPONT ACA PLUS THYROID STIMULATING HORMONE SYSTEM 10/03/1994
K770915 E. R. SQUIBB & SONS, INC. CLASP RIA KIT, HTSH 06/14/1977
K922701 E.I. DUPONT DE NEMOURS & CO., INC. DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD 09/09/1992
K922736 EASTMAN KODAK COMPANY KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA 07/10/1992
K973276 EG &G WALLAC AUTODELFIA NEONATAL HTSH L KIT (B077-112) 11/20/1997
K810948 ENDOCRINE-METABOLIC CENTER RADIOIMMUNOASSAY THYROID STIM. HORM. KIT 04/17/1981
K851148 EURO-DIAGNOSTICS BV TSH IRMA(125I) BTSI 1(THYROID STIMULA-HORMONE 04/29/1985
K960195 FRANKLIN DIAGNOSTICS, INC. THYROCHEK ONE-STEP RAPID TSH ASSAY 04/15/1996
K171103 Fujirebio Diagnostics, Inc. Lumipulse G TSH-III Immunoreaction Cartridges 07/28/2017
K771234 G.D. SEARLE AND CO. TSH RIA REAGENT SET 10/18/1977
K072458 GOLDEN BRIDGE INTERNATIONAL, INC. GBI TSH NEONATAL SCREENING KIT 04/10/2008
K780428 HOFFMANN-LA ROCHE, INC. ROCHE TSH RIA 03/30/1978
K843395 HYBRITECH, INC. ENCORE TSH REAGENT 10/11/1984
K822705 HYBRITECH, INC. TAMDEM-R THYROID STIMULATING HORMONE KIT 10/13/1982
K832813 HYBRITECH, INC. TANDEM-E THYROID STIMULATING HORMONE KIT 10/31/1983
K863859 HYBRITECH, INC. TANDEM-M IMMUNOENZYMETRIC ASSAY FOR THYR/STIM/HORM 11/21/1986
K920856 HYCOR BIOMEDICAL, INC. VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS 03/26/1992
K832823 ICL SCIENTIFIC ENZYMUNE-TEST TSH 10/14/1983
K913963 ICN BIOMEDICALS, INC. IMMUCHEM NEONATAL TSH-MP ELISA 12/13/1991
K920442 ICN BIOMEDICALS, INC. IMMUCHEM TSH-MW ELISA 03/18/1992
K883726 IMMUCHEM CORP. THYROID STIMULATING HORMONE (HTSH) IRMA NEONATAL 12/15/1988
K865071 IMMUCHEM CORP. THYROID STIMULATING HORMONE (TSH IRMA) RIA KIT 03/13/1987
K820089 IMMUNO ASSAY CORP. TSH (RIA) KIT 01/28/1982
K851980 IMMUNOTECH CORP. ENDAB TSH 05/31/1985
K903725 IMMUNOTECH CORP. EZ-BEAD TSH ENZYME IMMUNOASSAY KIT 10/26/1990
K910411 IMMUNOTECH CORP. MICROZYME TSH ENZYME IMMUNOASSAY KIT 04/03/1991
K896867 IN VITRO DIAGNOSTICS, INC. THYROID STIMULATING HORMONE-EIA-XT 02/23/1990
K952211 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. AMERLITE TSH-30 ULTRASENSITIVE ASSAY (LAN.0010Q/2010Q) 07/14/1995
K964558 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTICS PRODUCTS/TSH REAGENT PACK (GEM. 1001)/TSH CALIBRATORS(GEM.C001) 12/16/1996
K770892 KALLESTAD LABORATORIES, INC. TSH RADIOIMMUNOASSAY 06/14/1977
K852224 LECCO DIAGNOSTICS, INC. LEE-BEAD TSH(EIA) 07/09/1985
K853977 LEECO DIAGNOSTICS, INC. BETA-TSH-IRMA 10/22/1985
K813392 LEECO DIAGNOSTICS, INC. RADIOIMMUNOASSAY FOR HUMAN THYROID 12/22/1981
K990658 LITTLE NELL LABS, INC. THYROCHEK ONE-STEP WHOLE BLOOD RAPID TSH ASSAY 06/02/1999
K871644 LKB INSTRUMENTS, INC. DELFIA (TM) HTSH KIT 05/12/1987
K851120 LKB INSTRUMENTS, INC. DELFIA HTSH KIT 05/31/1985
K881443 LONDON DIAGNOSTICS, INC. LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY 05/27/1988
K110761 MAGNABIOSCIENCES, LLC MICT TSH 03/09/2012
K770604 MALLINCKRODT CRITICAL CARE RIA-DAC TM HTSH KIH 04/06/1977
K771377 MEDCOM DIAGNOSTICS, INC. THYRODOT-4, THYRODOT-SH 09/02/1977
K832499 MEDICAL & SCIENTIFIC DESIGNS, INC. PHASE II TSH KIT 09/12/1983
K921700 MEDIX BIOTECH, INC. TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093 06/29/1992
K874061 MEDIX BIOTECH, INC. TSH ENZYME IMMUNOASSAY TEST KIT NO. MB-1093 11/03/1987
K914756 MEDIX BIOTECH, INC. ULTRASENSITIVE TSH (U-TSH) ENZYME IMMUNO TEST KIT 01/15/1992
K791065 MELOY LABORATORIES, INC. IMMUNOSPOT TSH TEST 07/30/1979
K792562 MELOY LABORATORIES, INC. IMMUNOSTAT TSH TEST 01/16/1980
K871505 MICROMEDIC SYSTEMS AUTOPAK NEONATAL TSH MONOCLONAL IRMA KIT 05/26/1987
K832462 MICROMEDIC SYSTEMS AUTOPAK NEONATAL TSH RIA KIT 09/12/1983
K870245 MICROMEDIC SYSTEMS AUTOPAK TSH MONOCLONAL IRMA KIT 04/01/1987
K813525 MICROMEDIC SYSTEMS IN VITRO DIAGNOSTIC RADIOIMMUNOASSAY 12/31/1981
K860813 MICROMEDIC SYSTEMS MICROMEDIC HTSH MONOCLONAL IRMA KIT 07/14/1986
K813645 MICROMEDIC SYSTEMS MICROMEDIC HTSH RIA KIT 01/22/1982
K870904 MICROMEDIC SYSTEMS MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT 05/26/1987
K790260 MICROMEDIC SYSTEMS NTSH AUTOPAK TEST DELIVERY SYSTEM 03/21/1979
K771767 MILES LABORATORIES, INC. SERALUTE TSH (RIA) 10/25/1977
K971780 MONOBIND THYROTROPIN(TSH) ELISA 06/24/1997
K771222 MONOBIND TSH RIA TEST SYSTEM 08/04/1977
K063437 MONOBIND, INC. ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 04/04/2008
K131928 NANOEN TEK USA, INC. FREND TSH (REAGENT CARTRIDGE) 03/14/2014
K843281 NEOMETRICS, INC. ACCUSCREEN TSH 09/26/1984
K001455 NEOMETRICS, INC. ACCUWELL TSH, MODEL KAW-TSH-960 11/02/2000
K771590 NEW ENGLAND NUCLEAR THYROID STIMULATING HORMONE 09/15/1977
K903391 NICHOLS INSTITUTE ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM 10/12/1990
K853717 NICHOLS INSTITUTE DIAGNOSTICS ALLEGRO TM HS-TSH IMMUNOASSAY SYSTEM 10/02/1985
K950921 NICHOLS INSTITUTE DIAGNOSTICS CHEMILUMINESCENCE TSH 3RD GENERATION IMMUNOASSAY 05/02/1995
K961650 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT 07/16/1996
K833713 NUCLEAR DIAGNOSTICS, INC. SERUM THYROTROPIN ASSAY KIT, TIPSEP- 12/29/1983
K811558 NUCLEAR DIAGNOSTICS, INC. TSH-P.E.G. 06/18/1981
K852438 NUCLEAR MEDICAL LABORATORIES, INC. NML TSH IRMA 07/12/1985
K781296 NUCLEAR MEDICAL LABORATORIES, INC. THYRO-SHURE 08/31/1978
K844583 NUCLEAR MEDICAL LABORATORIES, INC. TSH-STAT 03/05/1985
K771378 NUCLEAR MEDICAL SYSTEMS, INC. NEO TSH-RIA KIT 10/18/1977
K062581 OLYMPUS AMERICA, INC. OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM 11/29/2006
K854087 ORGANON TEKNIKA CORP. NML TSH IRMA 10/25/1985
K791301 ORTHO DIAGNOSTICS, INC. ORTHO TSH RIA KIT 09/24/1979
K083173 ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM 12/22/2008
K081543 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM 10/23/2008
K883742 PACIFIC BIOTECH, INC. MODIFIED TSH IRMA KIT 01/03/1989
K862249 PACIFIC BIOTECH, INC. TSH IRMA KIT 06/27/1986
K843545 PACIFIC BIOTECH, INC. TSH QUIK RIA KIT 10/02/1984
K942658 PANTEX, DIV. BIO-ANALYSIS, INC. NEOSCREEN ELISA TSH 02/24/1995
K902333 PB DIAGNOSTIC SYSTEMS, INC. OPUS TSH TEST SYSTEM 07/05/1990
K780059 PCL-RIA, INC. RABBIT ANTIBODY/THYROID STIMUL. HORMONE 02/13/1978
K780015 PCL-RIA, INC. THYROID STIMULATING HORMONE 02/07/1978
K822935 PCL-RIA, INC. THYROID STIMULATING HORMONE 11/01/1982
K090846 PERKINELMER, INC. GSP INSTRUMENT AND GSP NEONATAL HTSH KIT 09/03/2009
K881627 PHARMACIA, INC. DELFIA(TM) NEONATAL HTSH KIT 10/03/1988
K905710 PHARMACIA, INC. PHARMACIA DELFIA NEONATAL HTSH KIT 02/21/1991
K011527 PRAXSYS BIOSYSTEMS, INC. PRAXSYS RELIA TSH TEST 08/07/2001
K052301 Qualigen, Inc. FASTPACK TSH IMMUNOASSAY 01/04/2006
K101390 Qualigen, Inc. FASTPACK TSH IMMUNOASSAY 08/13/2010
K792154 RADIOIMMUNOASSAY, INC. THYROID STIMULATING HORMONE 11/13/1979
K001606 REPROMEDIX CORP. REPROBEAD TSH ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 107) 10/05/2000
K801691 RIA DIAGNOSTICS TSH RIASSAY 08/27/1980
K930776 ROCHE DIAGNOSTIC SYSTEMS, INC. COBAS CORE TSH EIA 12/03/1993
K190773 Roche Diagnostics Elecsys TSH 04/16/2019
K162606 ROCHE DIAGNOSTICS Elecsys TSH assay, cobas e 801 Immunoassay analyzer 01/23/2017
K962464 SCANTIBODIES LABORATORY, INC. SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY) 10/08/1996
K881381 SCLAVO, INC. REAGENTS FOR TSH ASSAY 07/21/1988
K942661 SEALITE SCIENCES, INC. AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT 01/17/1995
K864677 SERONO DIAGNOSTICS, INC. TSH MAIACLONE IMMUNORADIOMETRIC ASSAY KIT/MAG SEP 01/07/1987
K872897 SERONO DIAGNOSTICS, INC. TSH SEROZYME IMMUNOENZYMETRIC KIT, MAG. SOLID PHA. 07/31/1987
K910837 SERONO-BAKER DIAGNOSTICS, INC. SRI TSH IMMUNENZYMETRIC ASSAY 05/24/1991
K162698 SHENZHEN NEW INDUSTRIES BIOMEDICAL ENGINEERING CO.,LTD MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer 07/14/2017
K083844 SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR TSH3-ULTRA METHOD 05/08/2009
K141999 Siemens Healthcare Diagnostics Inc. ADVIA CENTAUR TSH 04/22/2015
K081074 Siemens Healthcare Diagnostics Inc. DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 05/23/2008
K160647 Siemens Healthcare Diagnostics Inc. IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 05/31/2016
K150403 SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA Centaur TSH3-Ultra 05/01/2015
K151792 Siemens Healthcare Diagnostics,Inc. Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System 11/20/2015
K930050 SIGMA CHEMICAL CO. SIA THYROID STIMULATING HORMONE ELISA KIT 08/19/1993
K923532 SOLARCARE TECHNOLOGIES CORP,INC. NATIONAL SCREENING INSTITUTE MICRO-PLATE TSH ASSAY 03/12/1993
K821174 SQUIBB & SONS, INC. TSH-SQUIBB RADIOIMMUNOASSAY KIT 05/14/1982
K160541 SYSMEX AMERICA, INC. Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control 10/21/2016
K922138 SYVA CO. VISTA ULTRASENSITIVE HTSH ASSAY 07/21/1992
K811431 TECHNICON INSTRUMENTS CORP. TECHNICON STAR SYSTEM 06/09/1981
K961629 TECO DIAGNOSTICS THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST 09/11/1996
K861573 TERUMO MEDICAL CORP. TERUMO SENSIBEAD EIA TSH KIT 06/19/1986
K850376 TERUMO MEDICAL CORP. TERUMO SENSIBEAD EIA TSH KIT 03/04/1985
K030912 THRYOTEC THYRO TEST 07/25/2003
K972586 TOSOH MEDICS, INC. AIA-PACK TSH 3RD-GEN ASSAY 08/29/1997
K791855 UNION CARBIDE CORP. CENTRIA TSH RIA 10/17/1979
K864079 UNITED BIOTECH, INC. UBI MAGIWEL(TM) TSH QUANTITATIVE 12/16/1986
K861918 V-TECH, INC. V-TREND EIA TSH 07/02/1986
K885157 VENTREX LABORATORIES, INC. VENTREX COATED TUBE HIGH SENSITIVITY TSH 02/10/1989
K883342 VENTREX LABORATORIES, INC. VENTREX COATED TUBE TSH 09/13/1988
K830928 VENTREX LABORATORIES, INC. VENTREX ENZYME TSH KIT 04/28/1983
K801560 VENTREX LABORATORIES, INC. VENTREX/SEP TSH TEST SET 08/13/1980
K923401 WALLAC OY DELFIA HTSH ULTRA KIT 11/30/1992
K821620 YANG LABORATORIES, INC. (125I) HTSH RADIOIMMUNOASSAY KIT 06/14/1982


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