# K935286: Quantaphase II B12/Folate

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Feb 18, 1994 after 137 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
26 later devices descend from it; 5 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K973702: Elecsys Vitamin B12 Assay (1997), 10 descendants of its own
- K973674: Elecsys Folate (1997), 10 descendants of its own
- K060755: Elecsys Vitamin B12 Immunoassay, Calset II and Calcheck (2006), 9 descendants of its own
- K031756: Roche Diagnostics Elecsys Folate II Assay (2003), 9 descendants of its own
- K981931: Cedia Red Blood Cell Folate Reagent Pack, Cedia Folate Assay and Elecsys Folate Assay (1998), 9 descendants of its own

Source page: https://510kreport.com/device/K935286
Methodology: https://510kreport.com/methodology