Atlas FDA

CDD

78 FDA 510(k) clearances · Product code

80 daysmedian time to decision
201 days90th percentile
78clearances measured

FDA profile

Official device name
Radioassay, Vitamin B12
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1810
Medical specialty
Clinical Chemistry
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 28 · 2022: 24 · 2023: 27 · 2024: 33 · 2025: 45 · 2026: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
ARCHITECT Active-B12 (Holotranscobalamin) (K233541)Axis-Shield Diagnostics, Ltd.2024-07-31
Access Vitamin B12 (K223289)Beckman Coulter, Inc.2022-12-23
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 (K190298)Beckman Coulter Biomedical GmbH2019-10-04
LIAISON Vitamin B12 (K192064)DiaSorin, Inc.2019-10-02
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay (K172133)Axis-Shield Diagnostics, Ltd.2017-10-27
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set (K161721)Diazyme Laboratories2016-09-20
ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM) (K160757)Axis-Shield Diagnostics Limited2016-07-26
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet (K151786)Roche Diagnostics2015-09-24
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 (K140496)Beckman Coulter, Inc.2014-09-16
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL) (K133512)Siemens Healthcare Diagnostics2014-01-02
AXIS-SHIELD ACVTIVE-B12 (K121946)Axis-Shield Diagnostics, Ltd.2013-03-22
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR (K121994)Siemens Healthcare Diagnostics, Inc.2012-11-30
A/C ENZYMATIC VITAMIN B6 ASSAY (K111260)Anticancer, Inc.2012-07-26
ARCHITECT B12 (K121314)Abbott Laboratories2012-05-17
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) (K112443)Axis-Shield Diagnostics, Ltd.2011-12-19
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS (K110579)Abbott Laboratories2011-10-06
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS (K110413)Beckman Coulter, Inc.2011-05-11
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644 (K093631)Siemens Healthcare Diagnostics2010-02-12
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 (K090588)Beckman Coulter, Inc.2009-05-27
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR (K071224)Dade Behring, Inc.2007-11-13
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20; STANDARD CALIBRATOR KIT, MODEL 3L83-01; CONTROL KIT, MODEL 3L83-10 (K062467)Axis-Shield Diagnostics, Ltd.2006-11-22
IMMULITE 2500 VITAMIN B12 MODEL L5KVB2-200 TEST,L5KVB6-600 TEST, IMMULITE 2500 FOLIC ACID MODEL L5KFO2-200 TEST,L5KFO6-6 (K060929)Diagnostic Products Corporation2006-04-28
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK (K060755)Roche Diagnostics Corp.2006-04-10
ABBOTT AXSYM B12 (K051327)Abbott Laboratories2005-08-03
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER (K041133)Bayer Healthcare, LLC2004-07-02
HOLOTC RIA (K030655)Axis-Shield Biochemicals, Asa2004-01-29
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, CALIBRATORS (K013899)Ortho-Clinical Diagnostics2002-01-24
BAYER DIAGNOSTICS ACS:180 VB12, BAYER DIAGNOSTICS ADVIA CENTAUE VB12 (K993571)Bayer Corp.1999-12-16
VITROS IMMUNODIAGNOSTIC PRODUCTS VITAMIN B12, REAGENT PACK 1/2, FOLATE REAGENT PACK 3, ANF CALIBRATORS (K984321)Ortho-Clinical Diagnostics, Inc.1999-01-22
ELECSYS VITAMIN B12 ASSAY (K973702)Boehringer Mannheim Corp.1997-11-13
ELECSYS FOLATE (K973674)Boehringer Mannheim Corp.1997-11-12
IMMULITE VITAMIN B12 (LKVB1,LKVB5) (K971177)Diagnostic Products Corp.1997-05-16
AXSYM B12 (K965186)Abbott Laboratories1997-03-24
AIA-PACK B12 ASSAY (K964348)Tosoh Medics, Inc.1997-01-13
BUHLMANN VITAMIN B6 REA (K955561)American Laboratory Products Co., Ltd.1996-05-23
ACCESS VITAMIN B12 ASSAY (MODIFICATION) (K955436)Bio-Rad Laboratories, Inc.1996-01-24
OPUS B12 (K953455)Behring Diagnostics, Inc.1995-08-23
CEDIA VITAMIN B12 (NO BOIL) ASSAY (K951134)Microgenics Corp.1995-07-11
VISTA B12 ASSAY (K941235)Syva Co.1994-08-15
ACCESS VITAMIN B12 ASSAY (K933142)Bio-Rad Laboratories, Inc.1993-11-05
RADIAS B12 ENZYME IMMUNOASSAY (K933315)Bio-Rad1993-08-25
STRATUS VITAMIN B12 FLUOROMETRIC ENZYME-LINKED (K924074)Baxter Diagnostics, Inc.1992-10-26
AFFINITY B12 (K920078)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-02-14
CIBA CORNING ACS T3 IMMUNOASSAY (K913646)Ciba Corning Diagnostics Corp.1991-10-25
CIBA CORNING ACS VITAMIN B12 IMMUNOASSAY (K910343)Ciba Corning Diagnostics Corp.1991-03-06
CEDIA (R) VITAMIN B12/FOLATE ASSAY (K904776)Microgenics Corp.1990-11-20
CIBA CORNING MAGIC LITE VITAMIN B12 IMMUNOASSAY (K883722)Ciba Corning Diagnostics Corp.1988-11-04
SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) (K860815)Diagnostic Products Corp.1986-07-11
MAGIC NO BOIL B12/FOLATE RADIOIMMUNOASSAY (K854945)Ciba Corning Diagnostics Corp.1986-02-11
PHASE II B-12/FOLATE KIT (K853224)Medical & Scientific Designs, Inc.1985-10-03
MICROMEDIC COMBOSTAT B B12/FOLATE(BOIL) (K853127)Micromedic Systems1985-09-16
DIAGNON MONOCOMBO VITAM. B12[57CO]/FOLATE[125I] RA (K851377)Diagnon Corp.1985-08-21
VITAMIN B12 57CO/FOLATE 125I - (K840462)Corning Medical & Scientific1984-06-25
ANTIBODY TO INTRINSIC FACTOR RADIOASSAY (K833142)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-01-30
DIAGNON B12 57CO RIA KIT (K832717)Diagnon Corp.1983-12-08
QUANTAPHASE B-12-COBALMIN-FOLATE- (K833247)Bio-Rad1983-10-19
VITAMIN B12 FOLATE CA-1515-125 (K832711)Clinical Assays, Inc.1983-10-04
VITAMIN B12 RADIOASSAY KIT CA-1534 (K832710)Clinical Assays, Inc.1983-10-04
INTRINSIC FACTOR BLOCKING ANTIBODY KIT (K832726)Diagnostic Products Corp.1983-09-29
NO-BOIL SOLID PHASE SIMUL TRAC B12 (K822721)Bd Becton Dickinson Vacutainer Systems Preanalytic1983-03-10
NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID (K830195)Diagnostic Products Corp.1983-02-18
NO-BOIL VITABIN B12 5760 FOLATE 125I (K813183)Corning Medical & Scientific1982-03-05
NO-HOIL COMBOSTAT II KIT (K813310)Ria Products, Inc.1981-12-17
'NO-BOIL' VITAMIN B12 KIT (K810002)Diagnostic Products Corp.1981-01-16
VITAMIN B12 (57CO) RADIOIMMUNOASSAY (K802220)Corning Medical & Scientific1981-01-09
COMBOSTAT - NO-BOIL KIT (K801578)Ria Products, Inc.1980-10-23
VITAMIN B12 - NO-BOIL KIT (K801579)Ria Products, Inc.1980-10-23
CALBIOCHEM-BEHRING RIA-COUNT (K792460)Calbiochem-Behring Corp.1980-02-13
RIANEN, VITAMIN B12 ASSAY SYSTEM (K792175)New England Nuclear1979-11-13
CENTRIA VITAMIN B12 FOLATE RADIO SET (K791216)Ventrex Laboratories, Inc.1979-11-13
AUTO PAK VITAMIN B-12 (K790347)Micromedic Systems1979-09-27
RIA KIT, VITAMIN B12 (K782024)Technia Diagnostics , Ltd.1979-02-28
RIALYZE VITAMIN B-12 TEST (K781410)Ames Div., Miles Laboratories, Inc.1978-09-27
VITAMIN B12 RADIOASSAY (K780799)Amersham Corp.1978-06-13
QUANTA-MATE VITAMIN B-12/FOLATE RA (K771047)Bio-Rad1977-06-27
VITAMIN B12 RADIOASSAY (K761321)Kallestad Laboratories, Inc.1977-03-21
B12/FOLATE SING. TUBE DUAL RADIOASSAY KT (K760946)Schwarz Mann1976-12-21
RADIO IMMUNO ASSAY KIT/ (K760619)New England Nuclear1976-12-06

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