510(k) K963902 ยท GIS Test, Fibrinogen
QUANTITATIVE FIBRINOGEN ASSAY
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Nov 29, 1996 |
| Received | Sep 27, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963902
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.