# K972866: Hemochron JR. Miocrocoagulation Citrated PT

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: Sep 30, 1998 after 422 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 K940432 (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)
- K940432: Microcoagulation Prothrombin Time Test, International Technidyne Corp. (1994) Summary page 1.

## Indications for use
The Hemochrone Jr. Citrated PT is a unitized microcoagulation test intended for in vitro diagnostic use in performing a quantitative, one-stage prothrombin time. The Citrated PT test is performed using a citrated whole blood sample on the Hemochron® Jr. microcoagulation system. The instrument is portable and is intended for point of care testing. The instrument is not intended for home use.

Source page: https://510kreport.com/device/K972866
Methodology: https://510kreport.com/methodology