510(k) K935667 ยท GTY Antigens, All Groups, Streptococcus Spp.
QTEST(R) STREP
| Applicant | Becton Dickinson Advanced Diagnostics, Sparks MD, US |
| Decision | Substantially Equivalent, Apr 21, 1994 |
| Received | Nov 26, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K935667
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.