510(k) K891175 ยท GGL Control, White-Cell
EDL ABNORMAL COAGULATION CONTROL
| Applicant | Elite Diagnostic , Ltd., Indianapolis IN, US |
| Decision | Substantially Equivalent, Apr 10, 1989 |
| Received | Mar 6, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K891175
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.