# K940432: Microcoagulation Prothrombin Time Test

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: May 18, 1994 after 107 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K972866: Hemochron JR. Miocrocoagulation Citrated PT (1998), 0 descendants of its own

## Recalls of this device
- May 10, 2011 · Not classified · Z-2954-2011: Certain lots of Hemochron Jr. PT Cuvettes (J201) and GEM Test PT cartridges demonstrate a higher bias than historically observed when compared to laboratory reference. instruments.
- May 10, 2011 · Not classified · Z-2953-2011: Certain lots of Hemochron Jr. PT Cuvettes (J201) demonstrate a higher bias than historically observed when compared to laboratory reference instruments.

Source page: https://510kreport.com/device/K940432
Methodology: https://510kreport.com/methodology