# K974343: Dade Innovin

- Pathway: 510(k) (Traditional)
- Applicant: Dade Intl., Inc.
- Decided: Jul 22, 1998 after 245 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- 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 K891169 (1989). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K891169: Dade Thromboplastin IS, Baxter Healthcare Corp (1989) Summary page 1.

## Most influential descendants
- K991065: Careside PT (1999), 0 descendants of its own

## Indications for use
For use in prothrombin time determinations and prothrombin time-based assays.

Source page: https://510kreport.com/device/K974343
Methodology: https://510kreport.com/methodology