510(k) K960438 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
TINTELIZE PAI-1 KIT
| Applicant | Medical Diagnostic Technologies, Inc., Ventura CA, US |
| Decision | Substantially Equivalent, Jun 5, 1996 |
| Received | Jan 31, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960438
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.