510(k) K120977 ยท GGN Plasma, Coagulation Control
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
| Applicant | International Technidyne Corp., Edison NJ, US |
| Decision | Substantially Equivalent, Jul 3, 2013 |
| Received | Apr 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120977
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.