510(k) K983475 ยท KQG Instrument, Coagulation
HEMOCHRON RESPONSE
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, May 3, 1999 |
| Received | Oct 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983475
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2011 | International Technidyne Corp. Hemochron Whole Blood Coagulation Systems Activated Clotting Time (ACT); Package label states -International Technidyne Corporation Response Celite ACT Tube HRFTCA510; Lot number and expiration date a Terminated |
KQG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.