# K991321: Pacific Hemostasis Thromboscreen 200

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Hemostasis
- Decided: Jun 21, 1999 after 63 days
- Product code: KQG (Instrument, Coagulation)
- 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
Longest line of descent: 1 generation back to K884863 (1989). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884863: Electra 900C Automatic Coagulation Timer, Medical Laboratory Automation Systems, Inc. (1989) Summary page 1.
- K894052: Electra 1000C Automatic Coagulation Timer, Medical Laboratory Automation Systems, Inc. (1989) Summary page 1.

## Indications for use
The Pacific Hemostasis ThromboScreen® 200 is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing in the clinical laboratory. Coagulation testing capabilities of the device include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and Derived methods), as well as PT and APTT-based factor assays.

Source page: https://510kreport.com/device/K991321
Methodology: https://510kreport.com/methodology