# K964934: Thrombonostika F1.2

- Pathway: 510(k) (Traditional)
- Applicant: Organon Teknika Corp.
- Decided: Mar 18, 1997 after 99 days
- Product code: MIF (Prothrombin Fragment 1.2)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K911434 (1991). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911434: Thrombonostika F1.2, Organon Teknika Corp. (1991) Summary page 2.

## Indications for use
Thrombonostika F1.2 is an enzymed-linked immunosorbent assay for the quantitative determination of prothrombin activation fragment 1.2 (F1.2) in human plasma. It is indicated as an aid to both assess the risk of thrombosis and monitor the efficacy of anticoagulant therapy.

Source page: https://510kreport.com/device/K964934
Methodology: https://510kreport.com/methodology