510(k) K961835 ยท GJS Test, Time, Prothrombin
PROTIME MICROCOAGULATION SYSTEM
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Mar 12, 1997 |
| Received | May 13, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961835
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2008 | International Technidyne Corporation ProTime Microcoagulation System Instrument, Catalogue Number:
PROTIMEPST, International Technidyne Corporation (ITC), Piscataway, NJ 08854 Terminated |
GJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.