CDD · Class II · 21 CFR 862.1810

FDA Product Code CDD: Radioassay, Vitamin B12

Leading manufacturers include Diagnostic Products Corp., Abbott Laboratories and Beckman Coulter, Inc..

78
Total
78
Cleared
98d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Review times increasing: avg 271d recently vs 96d historically

FDA 510(k) Cleared Radioassay, Vitamin B12 Devices (Product Code CDD)

78 devices
1–24 of 78
Cleared Jul 31, 2024
ARCHITECT Active-B12 (Holotranscobalamin)
K233541
Axis-Shield Diagnostics, Ltd.
Chemistry · 271d
Cleared Dec 23, 2022
Access Vitamin B12
K223289
Beckman Coulter, Inc.
Chemistry · 59d
Cleared Oct 04, 2019
DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12
K190298
Beckman Coulter Biomedical GmbH
Chemistry · 235d
Cleared Oct 02, 2019
LIAISON Vitamin B12
K192064
DiaSorin, Inc.
Chemistry · 62d
Cleared Sep 16, 2014
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.
Chemistry · 201d
Cleared May 17, 2012
ARCHITECT B12
K121314
Abbott Laboratories
Chemistry · 15d
Cleared Oct 06, 2011
ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS
K110579
Abbott Laboratories
Chemistry · 219d
Cleared May 11, 2011
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS
K110413
Beckman Coulter, Inc.
Chemistry · 86d
Cleared May 27, 2009
POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210
K090588
Beckman Coulter, Inc.
Chemistry · 84d
Cleared Nov 13, 2007
DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR
K071224
Dade Behring, Inc.
Chemistry · 195d
Cleared Apr 10, 2006
ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK
K060755
Roche Diagnostics Corp.
Chemistry · 20d
Cleared Aug 03, 2005
ABBOTT AXSYM B12
K051327
Abbott Laboratories
Chemistry · 75d
Cleared Nov 13, 1997
ELECSYS VITAMIN B12 ASSAY
K973702
Boehringer Mannheim Corp.
Chemistry · 48d
Cleared Nov 12, 1997
ELECSYS FOLATE
K973674
Boehringer Mannheim Corp.
Chemistry · 47d
Cleared May 16, 1997
IMMULITE VITAMIN B12 (LKVB1,LKVB5)
K971177
Diagnostic Products Corp.
Chemistry · 46d
Cleared Mar 24, 1997
AXSYM B12
K965186
Abbott Laboratories
Chemistry · 90d
Cleared Aug 15, 1994
VISTA B12 ASSAY
K941235
Syva Co.
Chemistry · 153d
Cleared Aug 25, 1993
RADIAS B12 ENZYME IMMUNOASSAY
K933315
Bio-Rad
Chemistry · 49d
Cleared Feb 14, 1992
AFFINITY B12
K920078
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 37d
Cleared Jul 11, 1986
SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB)
K860815
Diagnostic Products Corp.
Chemistry · 129d
Cleared Jan 30, 1984
ANTIBODY TO INTRINSIC FACTOR RADIOASSAY
K833142
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 138d
Cleared Oct 19, 1983
QUANTAPHASE B-12-COBALMIN-FOLATE-
K833247
Bio-Rad
Chemistry · 19d
Cleared Sep 29, 1983
INTRINSIC FACTOR BLOCKING ANTIBODY KIT
K832726
Diagnostic Products Corp.
Immunology · 48d
Cleared Mar 10, 1983
NO-BOIL SOLID PHASE SIMUL TRAC B12
K822721
Bd Becton Dickinson Vacutainer Systems Preanalytic
Chemistry · 184d

About Product Code CDD - Regulatory Context

510(k) Submission Activity

78 total 510(k) submissions under product code CDD since 1976, with 78 receiving FDA clearance (average review time: 98 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - CDD Product Code

Recent submissions under CDD have taken an average of 271 days to reach a decision - up from 96 days historically. Manufacturers should account for longer review timelines in current project planning.

CDD devices are reviewed by the Chemistry panel. Browse all Chemistry devices →