FDA 510(k) Applications for Medical Device Product Code "CEW"
(Radioimmunoassay, Parathyroid Hormone)

FDA 510(k) Number Applicant Device Name Decision Date
K061190 BECKMAN COULTER, INC. ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 09/15/2006
K921949 BIO-RAD COTUBE PTH IRMA 09/02/1992
K063232 BIOKIT S.A. ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01 06/19/2007
K850254 CAMBRIDGE MEDICAL TECHNOLOGY PARATHYROID HORMONE RADIOIMMUNOASSAY KIT 04/03/1985
K882560 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE INTACT PTH IMMUNOASSAY 10/13/1988
K950211 CIS-US, INC. ELSA-PTH 04/13/1995
K934760 DIAGNOSTIC PRODUCTS CORP. "IMMUNLITE" INTACT PTH 12/10/1993
K930008 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT INTACT PTH IRMA 06/15/1993
K871970 DIAGNOSTIC PRODUCTS CORP. DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2 09/25/1987
K022603 DIAGNOSTIC PRODUCTS CORP. IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER 08/21/2002
K013566 DIAGNOSTIC PRODUCTS CORP. IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 11/20/2001
K011505 DIAGNOSTIC PRODUCTS CORP. IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 07/02/2001
K992105 DIAGNOSTIC PRODUCTS CORP. IMMULITE TURBO INTACT PTH, MODEL LSKPTZ 07/06/1999
K843871 DIAGNOSTIC PRODUCTS CORP. PARATHYROID HORMONE C-TERMINAL RIA KIT 10/30/1984
K843870 DIAGNOSTIC PRODUCTS CORP. PARATHYROID HORMONE MID-MOLECULE RIA-KIT 10/30/1984
K053533 DIAGNOSTIC PRODUCTS CORPORATION IMMULITE/IMMULITE 1000 TURBO INTACT PTH 02/03/2006
K830700 DIAGNOSTIC SYSTEMS MMH PTH RIA KIT 04/06/1983
K973514 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE INTACT PTH 10/31/1997
K952199 DIAGNOSTIC SYSTEMS LABORATORIES, INC. ACTIVE INTACT PTH ELISA 07/17/1995
K020945 DIAGNOSTIC SYSTEMS LABORATORIES, INC. AXSYM INTACT PTH, MODEL 2G06 05/31/2002
K853784 DIAGNOSTIC SYSTEMS LABORATORIES, INC. C-TERMINAL PTH RIA KIT 10/04/1985
K813203 DIAGNOSTIC SYSTEMS LABORATORIES, INC. C-TERMINAL PTH RIA TEST KIT, DSL-1000 12/03/1981
K896294 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL I-PTH (DSL #8000) 11/21/1989
K150879 DiaSorin Inc. LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers 06/22/2015
K033426 DIASORIN, INC. LIAISON N-TACT PTH 02/12/2004
K132515 DIASORIN, INC. LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS 11/08/2013
K821131 ENDOCRINE-METABOLIC CENTER RADIOIMMUNOASSAY PARATHYROID HORMONE MID 06/02/1982
K000471 FUTURE DIAGNOSTICS B.V. FUTURE DIAGNOSTICS B.V. STAT-INTRAOPERATIVE INTACT PTH KIT 04/11/2000
K941878 I.D.S. OCTEIA INTACT PTH 09/07/1994
K811566 IMMUNO NUCLEAR CORP. C-TERMINAL PTH BY RADIOIMMUNOASSAY KIT 06/25/1981
K830664 IMMUNO NUCLEAR CORP. HUMAN INTRACT PARATHYROID HORMONE BY 05/09/1983
K820228 IMMUNO NUCLEAR CORP. MIN-MOLECULE PTH BY RADIOIMMUNOASSAY 03/11/1982
K811418 IMMUNO NUCLEAR CORP. N-TERMINAL HPTH BY RIA 06/24/1981
K161158 IMMUNODIAGNOSTIC SYSTEMS LTD IDS-iSYS Intact PTHN 01/31/2017
K942369 IMMUNODIAGNOSTIC SYSTEMS LTD. GAMMA-BCT INTACT PTH 09/20/1994
K103325 IMMUNODIAGNOSTIC SYSTEMS LTD. IDS-ISYS INTACT PTH 02/03/2012
K874299 INCSTAR CORP. N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA) 11/23/1987
K921629 INCSTAR CORP. N-TACT(R) PTH SP KIT 05/14/1992
K901711 INCSTAR CORP. PTH-MM II 125I RADIOIMMUNOASSAY (RIA) 07/16/1990
K791128 INSTITUT NATIONAL DES RADIOELEMENTS PTH RIA 200 09/27/1979
K782081 ISO-TEX DIAGNOSTICS RIA SYSTEM, PARATHYROID HORMONE 03/21/1979
K772249 KALLESTAD LABORATORIES, INC. COMPLEMENT C3 NEPHELOMETRIC ASSAY 12/22/1977
K903130 LONDON DIAGNOSTICS, INC. LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY 09/25/1990
K861797 NICHOLS INSTITUTE DIAGNOSTICS ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY 07/22/1986
K843685 NICHOLS INSTITUTE DIAGNOSTICS C-TERMINAL/MID-MOLECULE PARATHYROID - 10/11/1984
K962033 NICHOLS INSTITUTE DIAGNOSTICS CHEMILUMINESCENCE INTRA-OPERATIVE INTACT PTH KIT 09/27/1996
K782010 NICHOLS INSTITUTE DIAGNOSTICS HORMONE KIT, PARATHYROID 01/10/1979
K954418 NICHOLS INSTITUTE DIAGNOSTICS INTACT PARATHYROID HORMONE (PTH) IMMUNOASSAY (MODIFICATION) 11/03/1995
K033302 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 01/26/2004
K033727 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY 04/22/2004
K013992 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNOASSAY 12/13/2001
K962598 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE KIT 12/10/1996
K040813 NICHOLS INSTITUTE DIAGNOSTICS NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 06/08/2004
K840379 NICHOLS INSTITUTE DIAGNOSTICS PARATHYROID HORMONE ANALYSIS PRODUCT 04/04/1984
K022472 NICHOLS INSTITUTE DIAGNOSTICS PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTACT PTH (1-84) 10/09/2002
K771783 NICHOLS INSTITUTE DIAGNOSTICS PTH RIA 10/14/1977
K101921 ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT 10/22/2010
K831470 RAMCO LABORATORIES, INC. PTH MR 06/22/1983
K992680 ROCHE DIAGNOSTICS CORP. ELECSYS PARATHYROID HORMONE TEST SYSTEM 09/28/1999
K070391 ROCHE DIAGNOSTICS CORP. ELECSYS PTH TEST SYSTEM 03/20/2007
K070709 ROCHE DIAGNOSTICS CORP. ROCHE ELECSYS PTH TEST SYSTEM 07/13/2007
K974306 SANGUI BIOTECH, INC. SANGUI BIOTECH, INC. INTACT-PTH (PARATHYROID HORMONE) ELISA 12/23/1997
K031534 SCANTIBODIES LABORATORY, INC. CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 07/30/2003
K944788 SCANTIBODIES LABORATORY, INC. INTACT PTH IMMUNORADIOMETRIC (IRMA) ASSAY (COATED BEAD-TECHNOLOGY) 07/19/1995
K060420 SCANTIBODIES LABORATORY, INC. MODIFICATION TO WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILLUMINOMETRIC (ICMA) ASSAY KIT, MODEL 3KG002 03/01/2006
K060348 SCANTIBODIES LABORATORY, INC. MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT 02/27/2006
K051150 SCANTIBODIES LABORATORY, INC. TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT 07/26/2005
K051888 SCANTIBODIES LABORATORY, INC. TOTAL INTACT PTH IMMUNORADIOMETRIC ASSAY (COATED TUBE VERSION), MODEL 3KG013 10/18/2005
K004038 SCANTIBODIES LABORATORY, INC. TOTAL PTH IMMUNORADIOMETRIC ASSAY(IRMA) DIAGNOSTIC KIT, MODEL 3KG600 04/30/2001
K051141 SCANTIBODIES LABORATORY, INC. WHOLE PTH (1-84) SPECIFIC IMMUNOCHEMILUMINOMETRIC ASSAY (ICMA), MODEL 3KG002 07/26/2005
K051810 SCANTIBODIES LABORATORY, INC. WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014 09/09/2005
K001411 SCANTIBODIES LABORATORY, INC. WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC IRMA DIAGNOSTIC ASSAY KIT, MODEL 3KG056 08/21/2000
K970483 SEALITE SCIENCES, INC. AQUALITE INTACT PTH 04/14/1997
K121981 SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY 03/21/2013
K133601 Siemens Healthcare Diagnostics Inc. ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY 02/05/2014
K163658 Siemens Healthcare Diagnostics Inc. ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay 05/23/2017
K833768 SORIN BIOMEDICA, FIAT, USA, INC. C. PTH RADIOIMMUNOASSAY KIT-CPTHK 12/29/1983
K844735 SYNCOR INTL. CORP. PTH-RIA 04/29/1985
K063605 Tosoh BioScience, Inc. ST AIA-PACK INTACT PTH ASSAY 06/21/2007
K822944 TRAVENOL LABORATORIES, S.A. GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT 12/30/1982
K913434 VENTREX LABORATORIES, INC. VENTREX COATED TUBE INTACT PTH 10/25/1991
K831069 WELLCOME DIAGNOSTICS DAC-CEL PTH KIT RD51 06/16/1983


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