# K943705: Folic Acid

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Oct 31, 1994 after 91 days
- Product code: CGN (Acid, Folic, Radioimmunoassay)
- Device class: 2
- Regulation: 21 CFR 862.1295
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K993254: Immulite 2000 Folic Acid, Model L2KF02, L2KF06 (1999), 1 descendant of its own
- K060929: Immulite 2500 Vitamin B12 Model L5KVB2-200 Test,L5KVB6-600 Test, Immulite 2500 Folic Acid Model L5KFO2-200 Test,L5KFO6-6 (2006), 0 descendants of its own

## Recalls of this device
- Nov 6, 2013 · Class II · Z-0569-2014: potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000 Folic Acid kit lots. This may lead to a failed adjustment before the labeled expiration date is reached

Source page: https://510kreport.com/device/K943705
Methodology: https://510kreport.com/methodology