510(k) K885003 ยท GTZ Antisera, All Groups, Streptococcus Spp.
BACTIGEN(R) GROUP B STREPTOCOCCUS TEST
| Applicant | Armkel, LLC, Cranbury NJ, US |
| Decision | Substantially Equivalent, Feb 7, 1989 |
| Received | Dec 1, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K885003
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.