510(k) K934314 ยท GGP Test, Qualitative And Quantitative Factor Deficiency
TINTELIZER(R) TPA
| Applicant | Biopool AB, Ontario, L7l 6b8, CA |
| Decision | Substantially Equivalent, Feb 23, 1994 |
| Received | Sep 1, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934314
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.