# K974711: Coamatic Plasminogen

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: May 1, 1998 after 135 days
- Product code: GGP (Test, Qualitative And Quantitative Factor Deficiency)
- Device class: 2
- Regulation: 21 CFR 864.7290
- 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 K854572 (1986). 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)
- K854572: Coatest Plasminogen, Kabivitrum, Inc. (1986) Summary page 1.

## Indications for use
Coamatic® Plasminogen is an in vitro diagnostic test for the quantitative determination of plasminogen (Plg) attivity in human citrated plasma on automated laboratory equipment and also using microplate and manual methods. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.

Source page: https://510kreport.com/device/K974711
Methodology: https://510kreport.com/methodology