510(k) K880029 ยท KFH Antiserum, Positive Control, Blastomyces Dermatitidis
EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001
| Applicant | Immuno-Mycologics, Inc., Norman OK, US |
| Decision | Substantially Equivalent, Feb 24, 1988 |
| Received | Jan 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880029
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.