# K961835: Protime Microcoagulation System

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: Mar 12, 1997 after 303 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 1 (0 Class I)
- 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.

## Recalls of this device
- Nov 19, 2007 · Not classified · Z-0547-2008: An increase in the frequency of non-conformance reports (NCMR) for certain displayed error messages at the point of routine Quality control checks for the Protime Microcoagulation System.

Source page: https://510kreport.com/device/K961835
Methodology: https://510kreport.com/methodology