CDD · Class II · 21 CFR 862.1810

FDA Product Code CDD: Radioassay, Vitamin B12

Leading manufacturers include Axis-Shield Diagnostics, Ltd., Diagnostic Products Corp. and Abbott Laboratories.

78
Total
78
Cleared
98d
Avg days
1976
Since
Declining activity - 0 submissions in the last 2 years vs 2 in the prior period

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 Oct 27, 2017
ADVIA Centaur Active-B12 (Holotranscobalamin) (AB12) Assay
K172133
Axis-Shield Diagnostics, Ltd.
Chemistry · 105d
Cleared Sep 20, 2016
Diazyme Vitamin B12 Assay, Diazyme Vitamin B12 Calibrators Set, Diazyme Vitamin B12 Controls Set
K161721
Diazyme Laboratories
Chemistry · 90d
Cleared Jul 26, 2016
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 Limited
Chemistry · 130d
Cleared Sep 24, 2015
Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet
K151786
Roche Diagnostics
Chemistry · 85d
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 Jan 02, 2014
LOCI VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, LOCI ANEMIA CALIBRATOR (ANEM CAL)
K133512
Siemens Healthcare Diagnostics
Chemistry · 48d
Cleared Mar 22, 2013
AXIS-SHIELD ACVTIVE-B12
K121946
Axis-Shield Diagnostics, Ltd.
Chemistry · 262d
Cleared Nov 30, 2012
DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR
K121994
Siemens Healthcare Diagnostics, Inc.
Chemistry · 147d
Cleared Jul 26, 2012
A/C ENZYMATIC VITAMIN B6 ASSAY
K111260
Anticancer, Inc.
Chemistry · 448d
Cleared May 17, 2012
ARCHITECT B12
K121314
Abbott Laboratories
Chemistry · 15d
Cleared Dec 19, 2011
ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN)
K112443
Axis-Shield Diagnostics, Ltd.
Chemistry · 117d
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 Feb 12, 2010
B12 REAGENT CARTRIDGE AND FOL FLEX REAGENT CARTRIDGE, MODEL RF642 AND RF644
K093631
Siemens Healthcare Diagnostics
Chemistry · 80d
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 Nov 22, 2006
AXSYM HOLO TC REAGENT KIT, MODEL 3L83-20
K062467
Axis-Shield Diagnostics, Ltd.
Chemistry · 90d
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 Jul 02, 2004
MODIFICATION TO BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K041133
Bayer Healthcare, LLC
Chemistry · 63d

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 declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.