510(k) K850772 ยท GTZ Antisera, All Groups, Streptococcus Spp.
BACTIGEN GROUP B STREPTOCOCCUS TEST
| Applicant | Armkel, LLC, Cranbury NJ, US |
| Decision | Substantially Equivalent, May 29, 1985 |
| Received | Feb 25, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K850772
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.