# K981206: Tas Results Data Acquisition System (Traqs)

- Pathway: 510(k) (Traditional)
- Applicant: Cardiovascular Diagnostics, Inc.
- Decided: May 26, 1998 after 55 days
- Product code: GKP (Instrument, Coagulation, Automated)
- Device class: 2
- Regulation: 21 CFR 864.5400
- 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 no predicate by number.

## Indications for use
The TRAQS is a database management system that is designed specifically to collect, organize, and store Thrombolytic Assessment System (TAS) analyzer records

Source page: https://510kreport.com/device/K981206
Methodology: https://510kreport.com/methodology