# K013155: Dade Thromboplastin C Plus

- Pathway: 510(k) (Traditional)
- Applicant: Dade Behring, Inc.
- Decided: Jan 18, 2002 after 119 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 K934326 (1994). 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)
- K934326: Multifibren U, Behring Diagnostics, Inc. (1994) Summary page 1.

## Indications for use
Dried Rabbit Brain Thromboplastin with Calcium. For use in prothrombin time (PT) determinations and prothrombin time based assays. *

Source page: https://510kreport.com/device/K013155
Methodology: https://510kreport.com/methodology