# K921684: PTT-LA Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: Jun 9, 1992 after 62 days
- Product code: GGW (Test, Time, Partial Thromboplastin)
- Device class: 2
- Regulation: 21 CFR 864.7925
- 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
- Apr 13, 2005 · Not classified · Z-1419-05: Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.

Source page: https://510kreport.com/device/K921684
Methodology: https://510kreport.com/methodology