# K970189: FIF TM

- Pathway: 510(k) (Traditional)
- Applicant: Panbio, Inc.
- Decided: May 21, 1997 after 120 days
- Product code: KQJ (System, Fibrinogen Determination)
- Device class: 2
- Regulation: 21 CFR 864.7340
- 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. The FDA summary names its predicate without a number.
- (no number) Baxter Dade Data-Fi Fibrinogen determination kit: named in the summary without a submission number

## Indications for use
A fibrinogen determination test is indicated for testing of conditions in which blood coagulation is involved. Such conditions include disseminated intravascular coaagulation, cardiovascular disease and primary fibrinolysis.

Source page: https://510kreport.com/device/K970189
Methodology: https://510kreport.com/methodology