# K834616: Amnio Stat-FLM Agglutination Test

- Pathway: 510(k) (Traditional)
- Applicant: Hana Biologics, Inc.
- Decided: May 25, 1984 after 163 days
- Product code: JHG (Chromatographic Separation, Lecithin/Sphingomyelin Ratio)
- Device class: 2
- Regulation: 21 CFR 862.1455
- Recalls of this device: none
- 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 has not posted a summary or statement for it, so its predicates are not known.

Source page: https://510kreport.com/device/K834616
Methodology: https://510kreport.com/methodology