510(k) K863647 ยท GTZ Antisera, All Groups, Streptococcus Spp.
CARDS(TM) STREP A CATALOG NO. CR-7545
| Applicant | Pacific Biotech, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Nov 26, 1986 |
| Received | Sep 18, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863647
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.