510(k) K974799 ยท JPA System, Multipurpose For In Vitro Coagulation Studies
HEMOCHRON JR GENERATION II, HEMOCHRON JR SIGNATURE
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Jul 7, 1998 |
| Received | Dec 22, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974799
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2011 | International Technidyne Corp. IL GEM PCL/PCL Plus - Gem Test PT Cartridge
ITC-Nexus Dx
A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time. Terminated |
JPA | None listed |
| Aug 5, 2011 | International Technidyne Corp. Hemochron JR. Microcoagulation Systems Prothrombin Time (PT).
International Ethidine Corp (ITC)-Nexus Dx.
A unitized mlcrocoagulation test intended for use in performing one-stage prothrombin time. Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.