510(k) K900396 ยท KFF Assay, Heparin
ORTHOKROME* HEPARIN
| Applicant | Ortho Diagnostic Systems, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent, Mar 15, 1990 |
| Received | Jan 29, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K900396
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.