510(k) K900395 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
ORTHOKROME* FACTOR VIII
| 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 K900395
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.