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CDD — Radioassay, Vitamin B12 Class II

FDA Device Classification

Classification Details

Product Code
CDD
Device Class
Class II
Regulation Number
862.1810
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K233541axis-shield diagnosticsARCHITECT Active-B12 (Holotranscobalamin)July 31, 2024
K223289beckman coulterAccess Vitamin B12December 23, 2022
K190298beckman coulter biomedicalDxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, AccOctober 4, 2019
K192064diasorinLIAISON Vitamin B12October 2, 2019
K172133axis-shield diagnosticsADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) AssayOctober 27, 2017
K161721diazyme laboratoriesDiazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin September 20, 2016
K160757axis-shield diagnostics limitedADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-July 26, 2016
K151786roche diagnosticsElecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSetSeptember 24, 2015
K140496beckman coulterAccess Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPSeptember 16, 2014
K133512siemens healthcare diagnosticsLOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CALJanuary 2, 2014
K121946axis-shield diagnosticsAXIS-SHIELD ACVTIVE-B12March 22, 2013
K121994siemens healthcare diagnosticsDIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI November 30, 2012
K111260anticancerA/C ENZYMATIC VITAMIN B6 ASSAYJuly 26, 2012
K121314abbott laboratoriesARCHITECT B12May 17, 2012
K112443axis-shield diagnosticsARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)December 19, 2011
K110579abbott laboratoriesARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLSOctober 6, 2011
K110413beckman coulterPOWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONSMay 11, 2011
K093631siemens healthcare diagnosticsB12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644February 12, 2010
K090588beckman coulterPOWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: May 27, 2009
K071224dade behringDIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRNovember 13, 2007