510(k) K896221 ยท GTZ Antisera, All Groups, Streptococcus Spp.
CARDS O.S.(TM) STREP A
| Applicant | Pacific Biotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Dec 13, 1989 |
| Received | Oct 30, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896221
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.