# K964349: Aia-Pack Folate Assay

- Pathway: 510(k) (Traditional)
- Applicant: Tosoh Medics, Inc.
- Decided: Nov 27, 1996 after 27 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Nov 30, 2018 · Class II · Z-0672-2019: 

Source page: https://510kreport.com/device/K964349
Methodology: https://510kreport.com/methodology