FDA 510(k) Applications for Medical Device Product Code "CDD"
(Radioassay, Vitamin B12)

FDA 510(k) Number Applicant Device Name Decision Date
K051327 ABBOTT LABORATORIES ABBOTT AXSYM B12 08/03/2005
K121314 ABBOTT LABORATORIES ARCHITECT B12 05/17/2012
K110579 ABBOTT LABORATORIES ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS 10/06/2011
K965186 ABBOTT LABORATORIES AXSYM B12 03/24/1997
K955561 AMERICAN LABORATORY PRODUCTS CO., LTD. BUHLMANN VITAMIN B6 REA 05/23/1996
K780799 AMERSHAM CORP. VITAMIN B12 RADIOASSAY 06/13/1978
K781410 AMES DIV., MILES LABORATORIES, INC. RIALYZE VITAMIN B-12 TEST 09/27/1978
K111260 ANTICANCER INC A/C ENZYMATIC VITAMIN B6 ASSAY 07/26/2012
K030655 AXIS-SHIELD BIOCHEMICALS, ASA HOLOTC RIA 01/29/2004
K112443 AXIS-SHIELD DIAGNOSTICS, LTD. ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) 12/19/2011
K121946 AXIS-SHIELD DIAGNOSTICS, LTD. AXIS-SHIELD ACVTIVE-B12 03/22/2013
K062467 AXIS-SHIELD DIAGNOSTICS, LTD. AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 11/22/2006
K924074 BAXTER DIAGNOSTICS, INC. STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED 10/26/1992
K993571 BAYER CORP. BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 12/16/1999
K041133 BAYER HEALTHCARE, LLC MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER 07/02/2004
K920078 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC AFFINITY B12 02/14/1992
K833142 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC ANTIBODY TO INTRINSIC FACTOR RADIOASSAY 01/30/1984
K822721 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC NO-BOIL SOLID PHASE SIMUL TRAC B12 03/10/1983
K140496 BECKMAN COULTER, INC. Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents 9/16/2014
K090588 BECKMAN COULTER, INC. POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 05/27/2009
K110413 BECKMAN COULTER, INC. POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS 05/11/2011
K953455 BEHRING DIAGNOSTICS, INC. OPUS B12 08/23/1995
K771047 BIO-RAD QUANTA-MATE VITAMIN B-12/FOLATE RA 06/27/1977
K833247 BIO-RAD QUANTAPHASE B-12-COBALMIN-FOLATE- 10/19/1983
K933315 BIO-RAD RADIAS B12 ENZYME IMMUNOASSAY 08/25/1993
K933142 BIO-RAD LABORATORIES, INC. ACCESS VITAMIN B12 ASSAY 11/05/1993
K955436 BIO-RAD LABORATORIES, INC. ACCESS VITAMIN B12 ASSAY (MODIFICATION) 01/24/1996
K973674 BOEHRINGER MANNHEIM CORP. ELECSYS FOLATE 11/12/1997
K973702 BOEHRINGER MANNHEIM CORP. ELECSYS VITAMIN B12 ASSAY 11/13/1997
K792460 CALBIOCHEM-BEHRING CORP. CALBIOCHEM-BEHRING RIA-COUNT 02/13/1980
K913646 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS T3 IMMUNOASSAY 10/25/1991
K910343 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY 03/06/1991
K883722 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY 11/04/1988
K854945 CIBA CORNING DIAGNOSTICS CORP. MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY 02/11/1986
K832711 CLINICAL ASSAYS, INC. VITAMIN B12 FOLATE CA-1515-125 10/04/1983
K832710 CLINICAL ASSAYS, INC. VITAMIN B12 RADIOASSAY KIT CA-1534 10/04/1983
K813183 CORNING MEDICAL & SCIENTIFIC NO-BOIL VITABIN B12 5760 FOLATE 125I 03/05/1982
K802220 CORNING MEDICAL & SCIENTIFIC VITAMIN B12 (57CO) RADIOIMMUNOASSAY 01/09/1981
K840462 CORNING MEDICAL & SCIENTIFIC VITAMIN B12 57CO/FOLATE 125I - 06/25/1984
K071224 DADE BEHRING, INC. DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR 11/13/2007
K832717 DIAGNON CORP. DIAGNON B12 57CO RIA KIT 12/08/1983
K851377 DIAGNON CORP. DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA 08/21/1985
K810002 DIAGNOSTIC PRODUCTS CORP. 'NO-BOIL' VITAMIN B12 KIT 01/16/1981
K971177 DIAGNOSTIC PRODUCTS CORP. IMMULITE VITAMIN B12 (LKVB1,LKVB5) 05/16/1997
K832726 DIAGNOSTIC PRODUCTS CORP. INTRINSIC FACTOR BLOCKING ANTIBODY KIT 09/29/1983
K830195 DIAGNOSTIC PRODUCTS CORP. NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID 02/18/1983
K860815 DIAGNOSTIC PRODUCTS CORP. SOLID PHASE BOIL DUALCOUNT ("DUALCOUNT SPB") 07/11/1986
K060929 DIAGNOSTIC PRODUCTS CORPORATION IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 04/28/2006
K761321 KALLESTAD LABORATORIES, INC. VITAMIN B12 RADIOASSAY 03/21/1977
K853224 MEDICAL & SCIENTIFIC DESIGNS, INC. PHASE II B-12/FOLATE KIT 10/03/1985
K904776 MICROGENICS CORP. CEDIA (R) VITAMIN B12/FOLATE ASSAY 11/20/1990
K951134 MICROGENICS CORP. CEDIA VITAMIN B12 (NO BOIL) ASSAY 07/11/1995
K790347 MICROMEDIC SYSTEMS AUTO PAK VITAMIN B-12 09/27/1979
K853127 MICROMEDIC SYSTEMS MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL) 09/16/1985
K760619 NEW ENGLAND NUCLEAR RADIO IMMUNO ASSAY KIT/ 12/06/1976
K792175 NEW ENGLAND NUCLEAR RIANEN, VITAMIN B12 ASSAY SYSTEM 11/13/1979
K013899 ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS 01/24/2002
K984321 ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS 01/22/1999
K801578 RIA PRODUCTS, INC. COMBOSTAT - NO-BOIL KIT 10/23/1980
K813310 RIA PRODUCTS, INC. NO-HOIL COMBOSTAT II KIT 12/17/1981
K801579 RIA PRODUCTS, INC. VITAMIN B12 - NO-BOIL KIT 10/23/1980
K151786 Roche Diagnostics Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet 9/24/2015
K060755 ROCHE DIAGNOSTICS CORP. ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK 04/10/2006
K760946 SCHWARZ MANN B12/FOLATE SING. TUBE DUAL RADIOASSAY KT 12/21/1976
K093631 SIEMENS HEALTHCARE DIAGNOSTICS B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 02/12/2010
K133512 SIEMENS HEALTHCARE DIAGNOSTICS LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) 01/02/2014
K121994 SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR 11/30/2012
K941235 SYVA CO. VISTA B12 ASSAY 08/15/1994
K782024 TECHNIA DIAGNOSTICS LTD. RIA KIT, VITAMIN B12 02/28/1979
K964348 TOSOH MEDICS, INC. AIA-PACK B12 ASSAY 01/13/1997
K791216 VENTREX LABORATORIES, INC. CENTRIA VITAMIN B12 FOLATE RADIO SET 11/13/1979


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