510(k) K941001 ยท GIS Test, Fibrinogen
ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT
| Applicant | Diagnostic Specialties, Metuchen NJ, US |
| Decision | Substantially Equivalent, Aug 30, 1994 |
| Received | Mar 1, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941001
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.