Panels › Clinical Chemistry › Product code CDD · Class 2
Radioassay, Vitamin B12
Regulation 862.1810
0510(k)s in 12 months (78 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
Top companies in CDD
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 11, 2025 | Beckman Coulter, Inc. Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 Completed |
CDD | K955436 |
| Sep 5, 2024 | Beckman Coulter Biomedical GmbH PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express. Open, Classified |
CDD | K140496 |
| Sep 5, 2024 | Beckman Coulter Biomedical GmbH PE Centrifuge, REF: B36365, a component of the Power Express Open, Classified |
CDD | K140496 |
| Sep 5, 2024 | Beckman Coulter Biomedical GmbH Power Express, REF B90918 Open, Classified |
CDD | K140496 |
| Oct 14, 2021 | Beckman Coulter Inc. Power Processor 3K, 3K High Speed Stockyards
Module Nameplate:
PP 3K Stockyard (Refrig) 9707 REF A88116 Open, Classified |
CDD | K110413 |
| Nov 15, 2019 | Tosoh Smd Inc AIA-PACK B12 Pretreatment Set- IVD for diagnostic use for pre-treatment of calibrators/controls. Part Number: 020706 Terminated |
CDD | K964348 |
| Nov 30, 2018 | Tosoh Bioscience Inc AIA-PACK B12 (Vitamin B12) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of vitamin B12 (B12) in human serum on Tosoh AIA System analyzers. Terminated |
CDD | K964348 |
| Aug 28, 2018 | Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Vitamin B12 Reagent Pack 1/2, Catalog Number 1453489
For in vitro diagnostic use only For the quantitative measurement of vitamin B12 in human serum and plasma (EDTA Terminated |
CDD | K013899 K984321 |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE /IMMULITE 1000 Vitamin B12 Terminated |
CDD | K971177 |
| Jun 27, 2012 | Siemens Healthcare Diagnostics, Inc. Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442)
B12 Flex Reagent Cartridge used with the Dimension Vista System for the in vitro diagnostic test for the quantitative measureme Terminated |
CDD | K071224 |
| Mar 1, 2007 | Siemens Medical Solutions Diagnostics Sample Management System software for in vitro diagnostic testing
Product # 030102-03 Terminated |
CDD | None listed |
| Feb 11, 2005 | Diagnostic Products Corp IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186. Terminated |
CDD | K993251 |
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