# K955843: Tas Ptone

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Diagnostic Services
- Decided: Mar 18, 1996 after 83 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 K882456 (1988). 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)
- K882456: Coag-I PT Test Card, Cardiovascular Diagnostic Services (1988) Summary page 2.

## Indications for use
The new TAS PT ONE test card, is intended to be used with the TAS Analyzer to determine the prothrombin time in citrated whole blood or plasma.

Source page: https://510kreport.com/device/K955843
Methodology: https://510kreport.com/methodology