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Panels › Clinical Chemistry › Product code CDD · Class 2

Radioassay, Vitamin B12

Regulation 862.1810

0510(k)s in 12 months (78 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
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Top companies in CDD

Company510(k)sRecalls
Diagnostic Products Corp.61
Axis-Shield Diagnostics Limited60
Beckman Coulter, Inc.42
Siemens Healthcare Diagnostics32
Abbott Laboratories40
Beckman Coulter Biomedical GmbH13
Ciba Corning Diagnostics Corp.40
Bd Becton Dickinson Vacutainer Systems Preanalytic30
Bio-Rad30
Corning Medical & Scientific30
Decided510(k)Device and applicantCode
Jul 31, 2024K233541ARCHITECT Active-B12 (Holotranscobalamin)
Axis-Shield Diagnostics, Ltd., GB
CDD
Dec 23, 2022K223289Access Vitamin B12
Beckman Coulter, Inc.
CDD
Oct 4, 2019K190298DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
Beckman Coulter Biomedical GmbH, DE
CDD
Oct 2, 2019K192064LIAISON Vitamin B12
DiaSorin, Inc.
CDD
Oct 27, 2017K172133ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
Axis-Shield Diagnostics, Ltd., GB
CDD
Sep 20, 2016K161721Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
Diazyme Laboratories
CDD
Jul 26, 2016K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Cen
Axis-Shield Diagnostics Limited, GB
CDD
Sep 24, 2015K151786Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
Roche Diagnostics
CDD
Sep 16, 2014K140496Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sa
Beckman Coulter, Inc.
CDD
Jan 2, 2014K133512LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
Siemens Healthcare Diagnostics
CDD
Mar 22, 2013K121946AXIS-SHIELD ACVTIVE-B12
Axis-Shield Diagnostics, Ltd., GB
CDD
Nov 30, 2012K121994DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
Siemens Healthcare Diagnostics, Inc.
CDD
Jul 26, 2012K111260A/C ENZYMATIC VITAMIN B6 ASSAY
Anticancer, Inc.
CDD
May 17, 2012K121314ARCHITECT B12
Abbott Laboratories
CDD
Dec 19, 2011K112443ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
Axis-Shield Diagnostics, Ltd., GB
CDD
Oct 6, 2011K110579ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
Abbott Laboratories
CDD
May 11, 2011K110413POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
Beckman Coulter, Inc.
CDD
Feb 12, 2010K093631B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
Siemens Healthcare Diagnostics
CDD
May 27, 2009K090588POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
Beckman Coulter, Inc.
CDD
Nov 13, 2007K071224DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
Dade Behring, Inc.
CDD
Nov 22, 2006K062467AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10
Axis-Shield Diagnostics, Ltd., GB
CDD
Apr 28, 2006K060929IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6
Diagnostic Products Corporation
CDD
Apr 10, 2006K060755ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
Roche Diagnostics Corp.
CDD
Aug 3, 2005K051327ABBOTT AXSYM B12
Abbott Laboratories
CDD
Jul 2, 2004K041133MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
Bayer Healthcare, LLC
CDD
Jan 29, 2004K030655HOLOTC RIA
Axis-Shield Biochemicals, Asa
CDD
Jan 24, 2002K013899VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS
Ortho-Clinical Diagnostics
CDD
Dec 16, 1999K993571BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12
Bayer Corp.
CDD
Jan 22, 1999K984321VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS
Ortho-Clinical Diagnostics, Inc.
CDD
Nov 13, 1997K973702ELECSYS VITAMIN B12 ASSAY
Boehringer Mannheim Corp.
CDD
Nov 12, 1997K973674ELECSYS FOLATE
Boehringer Mannheim Corp.
CDD
May 16, 1997K971177IMMULITE VITAMIN B12 (LKVB1,LKVB5)
Diagnostic Products Corp.
CDD
Mar 24, 1997K965186AXSYM B12
Abbott Laboratories
CDD
Jan 13, 1997K964348AIA-PACK B12 ASSAY
Tosoh Medics, Inc.
CDD
May 23, 1996K955561BUHLMANN VITAMIN B6 REA
American Laboratory Products Co., Ltd.
CDD
Jan 24, 1996K955436ACCESS VITAMIN B12 ASSAY (MODIFICATION)
Bio-Rad Laboratories, Inc.
CDD
Aug 23, 1995K953455OPUS B12
Behring Diagnostics, Inc.
CDD
Jul 11, 1995K951134CEDIA VITAMIN B12 (NO BOIL) ASSAY
Microgenics Corp.
CDD
Aug 15, 1994K941235VISTA B12 ASSAY
Syva Co.
CDD
Nov 5, 1993K933142ACCESS VITAMIN B12 ASSAY
Bio-Rad Laboratories, Inc.
CDD
Aug 25, 1993K933315RADIAS B12 ENZYME IMMUNOASSAY
Bio-Rad
CDD
Oct 26, 1992K924074STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED
Baxter Diagnostics, Inc.
CDD
Feb 14, 1992K920078AFFINITY B12
Bd Becton Dickinson Vacutainer Systems Preanalytic
CDD
Oct 25, 1991K913646CIBA CORNING ACS T3 IMMUNOASSAY
Ciba Corning Diagnostics Corp.
CDD
Mar 6, 1991K910343CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY
Ciba Corning Diagnostics Corp.
CDD
Nov 20, 1990K904776CEDIA (R) VITAMIN B12/FOLATE ASSAY
Microgenics Corp.
CDD
Nov 4, 1988K883722CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY
Ciba Corning Diagnostics Corp.
CDD
Jul 11, 1986K860815SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)
Diagnostic Products Corp.
CDD
Feb 11, 1986K854945MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY
Ciba Corning Diagnostics Corp.
CDD
Oct 3, 1985K853224PHASE II B-12/FOLATE KIT
Medical & Scientific Designs, Inc.
CDD

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