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 |
| K111260 | ANTICANCER INC | A/C ENZYMATIC VITAMIN B6 ASSAY | 07/26/2012 |
| K030655 | AXIS-SHIELD BIOCHEMICALS, ASA | HOLOTC RIA | 01/29/2004 |
| K160757 | AXIS-SHIELD DIAGNOSTICS LIMITED | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) | 07/26/2016 |
| K172133 | Axis-Shield Diagnostics Ltd. | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | 10/27/2017 |
| 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 |
| 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 |
| K190298 | Beckman Coulter Biomedical GmbH | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 | 10/04/2019 |
| K223289 | Beckman Coulter, Inc. | Access Vitamin B12 | 12/23/2022 |
| 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 | 09/16/2014 |
| 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 |
| 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 |
| K071224 | DADE BEHRING, INC. | DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR | 11/13/2007 |
| K971177 | DIAGNOSTIC PRODUCTS CORP. | IMMULITE VITAMIN B12 (LKVB1,LKVB5) | 05/16/1997 |
| 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 |
| K192064 | DiaSorin Inc. | LIAISON Vitamin B12 | 10/02/2019 |
| K161721 | Diazyme Laboratories | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set | 09/20/2016 |
| 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 |
| K151786 | Roche Diagnostics | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet | 09/24/2015 |
| K060755 | ROCHE DIAGNOSTICS CORP. | ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK | 04/10/2006 |
| 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 |
| K964348 | TOSOH MEDICS, INC. | AIA-PACK B12 ASSAY | 01/13/1997 |
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