FDA Product Code
FDA Product Code CDD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1810
510(k) Clearances — 78 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K233541 | ARCHITECT Active-B12 (Holotranscobalamin) | Axis-Shield Diagnostics, Ltd. | 2024-07-31 | Traditional | PDF ↗ |
| K223289 | Access Vitamin B12 | Beckman Coulter, Inc. | 2022-12-23 | Traditional | PDF ↗ |
| K190298 | DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 | Beckman Coulter Biomedical GmbH | 2019-10-04 | Traditional | PDF ↗ |
| K192064 | LIAISON Vitamin B12 | DiaSorin, Inc. | 2019-10-02 | Traditional | PDF ↗ |
| K172133 | ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay | Axis-Shield Diagnostics, Ltd. | 2017-10-27 | Special | PDF ↗ |
| K161721 | Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set | Diazyme Laboratories | 2016-09-20 | Traditional | PDF ↗ |
| K160757 | ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) | Axis-Shield Diagnostics Limited | 2016-07-26 | Traditional | PDF ↗ |
| K151786 | Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet | Roche Diagnostics | 2015-09-24 | Traditional | PDF ↗ |
| K140496 | 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 | Beckman Coulter, Inc. | 2014-09-16 | Special | PDF ↗ |
| K133512 | LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) | Siemens Healthcare Diagnostics | 2014-01-02 | Traditional | PDF ↗ |
| K121946 | AXIS-SHIELD ACVTIVE-B12 | Axis-Shield Diagnostics, Ltd. | 2013-03-22 | Traditional | PDF ↗ |
| K121994 | DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR | Siemens Healthcare Diagnostics, Inc. | 2012-11-30 | Traditional | PDF ↗ |
| K111260 | A/C ENZYMATIC VITAMIN B6 ASSAY | Anticancer, Inc. | 2012-07-26 | Traditional | PDF ↗ |
| K121314 | ARCHITECT B12 | Abbott Laboratories | 2012-05-17 | Traditional | PDF ↗ |
| K112443 | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | Axis-Shield Diagnostics, Ltd. | 2011-12-19 | Traditional | PDF ↗ |
| K110579 | ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS | Abbott Laboratories | 2011-10-06 | Traditional | PDF ↗ |
| K110413 | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS | Beckman Coulter, Inc. | 2011-05-11 | Special | PDF ↗ |
| K093631 | B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 | Siemens Healthcare Diagnostics | 2010-02-12 | Special | PDF ↗ |
| K090588 | POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 | Beckman Coulter, Inc. | 2009-05-27 | Traditional | PDF ↗ |
| K071224 | DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR | Dade Behring, Inc. | 2007-11-13 | Traditional | PDF ↗ |
| K062467 | AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 | Axis-Shield Diagnostics, Ltd. | 2006-11-22 | Traditional | PDF ↗ |
| K060929 | IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 | Diagnostic Products Corporation | 2006-04-28 | Special | PDF ↗ |
| K060755 | ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK | Roche Diagnostics Corp. | 2006-04-10 | Special | PDF ↗ |
| K051327 | ABBOTT AXSYM B12 | Abbott Laboratories | 2005-08-03 | Traditional | PDF ↗ |
| K041133 | MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER | Bayer Healthcare, LLC | 2004-07-02 | Special | PDF ↗ |
| K030655 | HOLOTC RIA | Axis-Shield Biochemicals, Asa | 2004-01-29 | Traditional | PDF ↗ |
| K013899 | VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS | Ortho-Clinical Diagnostics | 2002-01-24 | Traditional | PDF ↗ |
| K993571 | BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 | Bayer Corp. | 1999-12-16 | Traditional | PDF ↗ |
| K984321 | VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS | Ortho-Clinical Diagnostics, Inc. | 1999-01-22 | Traditional | PDF ↗ |
| K973702 | ELECSYS VITAMIN B12 ASSAY | Boehringer Mannheim Corp. | 1997-11-13 | Traditional | PDF ↗ |
| K973674 | ELECSYS FOLATE | Boehringer Mannheim Corp. | 1997-11-12 | Traditional | PDF ↗ |
| K971177 | IMMULITE VITAMIN B12 (LKVB1,LKVB5) | Diagnostic Products Corp. | 1997-05-16 | Traditional | PDF ↗ |
| K965186 | AXSYM B12 | Abbott Laboratories | 1997-03-24 | Traditional | PDF ↗ |
| K964348 | AIA-PACK B12 ASSAY | Tosoh Medics, Inc. | 1997-01-13 | Traditional | PDF ↗ |
| K955561 | BUHLMANN VITAMIN B6 REA | American Laboratory Products Co., Ltd. | 1996-05-23 | Traditional | PDF ↗ |
| K955436 | ACCESS VITAMIN B12 ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1996-01-24 | Traditional | PDF ↗ |
| K953455 | OPUS B12 | Behring Diagnostics, Inc. | 1995-08-23 | Traditional | PDF ↗ |
| K951134 | CEDIA VITAMIN B12 (NO BOIL) ASSAY | Microgenics Corp. | 1995-07-11 | Traditional | PDF ↗ |
| K941235 | VISTA B12 ASSAY | Syva Co. | 1994-08-15 | Traditional | PDF ↗ |
| K933142 | ACCESS VITAMIN B12 ASSAY | Bio-Rad Laboratories, Inc. | 1993-11-05 | Traditional | PDF ↗ |
| K933315 | RADIAS B12 ENZYME IMMUNOASSAY | Bio-Rad | 1993-08-25 | Traditional | PDF ↗ |
| K924074 | STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED | Baxter Diagnostics, Inc. | 1992-10-26 | Traditional | PDF ↗ |
| K920078 | AFFINITY B12 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-02-14 | Traditional | PDF ↗ |
| K913646 | CIBA CORNING ACS T3 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-10-25 | Traditional | PDF ↗ |
| K910343 | CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-03-06 | Traditional | PDF ↗ |
| K904776 | CEDIA (R) VITAMIN B12/FOLATE ASSAY | Microgenics Corp. | 1990-11-20 | Traditional | PDF ↗ |
| K883722 | CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1988-11-04 | Traditional | PDF ↗ |
| K860815 | SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) | Diagnostic Products Corp. | 1986-07-11 | Traditional | PDF ↗ |
| K854945 | MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1986-02-11 | Traditional | PDF ↗ |
| K853224 | PHASE II B-12/FOLATE KIT | Medical & Scientific Designs, Inc. | 1985-10-03 | Traditional | PDF ↗ |
| K853127 | MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL) | Micromedic Systems | 1985-09-16 | Traditional | PDF ↗ |
| K851377 | DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA | Diagnon Corp. | 1985-08-21 | Traditional | PDF ↗ |
| K840462 | VITAMIN B12 57CO/FOLATE 125I - | Corning Medical & Scientific | 1984-06-25 | Traditional | PDF ↗ |
| K833142 | ANTIBODY TO INTRINSIC FACTOR RADIOASSAY | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-01-30 | Traditional | PDF ↗ |
| K832717 | DIAGNON B12 57CO RIA KIT | Diagnon Corp. | 1983-12-08 | Traditional | PDF ↗ |
| K833247 | QUANTAPHASE B-12-COBALMIN-FOLATE- | Bio-Rad | 1983-10-19 | Traditional | PDF ↗ |
| K832710 | VITAMIN B12 RADIOASSAY KIT CA-1534 | Clinical Assays, Inc. | 1983-10-04 | Traditional | PDF ↗ |
| K832711 | VITAMIN B12 FOLATE CA-1515-125 | Clinical Assays, Inc. | 1983-10-04 | Traditional | PDF ↗ |
| K832726 | INTRINSIC FACTOR BLOCKING ANTIBODY KIT | Diagnostic Products Corp. | 1983-09-29 | Traditional | PDF ↗ |
| K822721 | NO-BOIL SOLID PHASE SIMUL TRAC B12 | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-03-10 | Traditional | PDF ↗ |
| K830195 | NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID | Diagnostic Products Corp. | 1983-02-18 | Traditional | PDF ↗ |
| K813183 | NO-BOIL VITABIN B12 5760 FOLATE 125I | Corning Medical & Scientific | 1982-03-05 | Traditional | PDF ↗ |
| K813310 | NO-HOIL COMBOSTAT II KIT | Ria Products, Inc. | 1981-12-17 | Traditional | PDF ↗ |
| K810002 | 'NO-BOIL' VITAMIN B12 KIT | Diagnostic Products Corp. | 1981-01-16 | Traditional | PDF ↗ |
| K802220 | VITAMIN B12 (57CO) RADIOIMMUNOASSAY | Corning Medical & Scientific | 1981-01-09 | Traditional | PDF ↗ |
| K801579 | VITAMIN B12 - NO-BOIL KIT | Ria Products, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K801578 | COMBOSTAT - NO-BOIL KIT | Ria Products, Inc. | 1980-10-23 | Traditional | PDF ↗ |
| K792460 | CALBIOCHEM-BEHRING RIA-COUNT | Calbiochem-Behring Corp. | 1980-02-13 | Traditional | PDF ↗ |
| K792175 | RIANEN, VITAMIN B12 ASSAY SYSTEM | New England Nuclear | 1979-11-13 | Traditional | PDF ↗ |
| K791216 | CENTRIA VITAMIN B12 FOLATE RADIO SET | Ventrex Laboratories, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K790347 | AUTO PAK VITAMIN B-12 | Micromedic Systems | 1979-09-27 | Traditional | PDF ↗ |
| K782024 | RIA KIT, VITAMIN B12 | Technia Diagnostics , Ltd. | 1979-02-28 | Traditional | PDF ↗ |
| K781410 | RIALYZE VITAMIN B-12 TEST | Ames Div., Miles Laboratories, Inc. | 1978-09-27 | Traditional | PDF ↗ |
| K780799 | VITAMIN B12 RADIOASSAY | Amersham Corp. | 1978-06-13 | Traditional | PDF ↗ |
| K771047 | QUANTA-MATE VITAMIN B-12/FOLATE RA | Bio-Rad | 1977-06-27 | Traditional | PDF ↗ |
| K761321 | VITAMIN B12 RADIOASSAY | Kallestad Laboratories, Inc. | 1977-03-21 | Traditional | PDF ↗ |
| K760946 | B12/FOLATE SING. TUBE DUAL RADIOASSAY KT | Schwarz Mann | 1976-12-21 | Traditional | PDF ↗ |
| K760619 | RADIO IMMUNO ASSAY KIT/ | New England Nuclear | 1976-12-06 | Traditional | PDF ↗ |
Product code CDD · Class II · Clinical Chemistry. Data: openFDA.