# K933142: Access Vitamin B12 Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Nov 5, 1993 after 130 days
- Product code: CDD (Radioassay, Vitamin B12)
- Device class: 2
- Regulation: 21 CFR 862.1810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013899: Vitros Immunodiagnostic Products Vitamin B12, Reagent Pack 1/2, Folate Reagent Pack 3, Calibrators (2002), 0 descendants of its own

Source page: https://510kreport.com/device/K933142
Methodology: https://510kreport.com/methodology