510(k) K905020 ยท GTY Antigens, All Groups, Streptococcus Spp.
SLIDEX STREPTO-KIT
| Applicant | Vitek Systems, Inc., Hazelwood MI, US |
| Decision | Substantially Equivalent, Jan 28, 1991 |
| Received | Nov 7, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905020
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.