510(k) K802308 ยท DBM Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
T/K (ATA/AMA) UNIVERSAL BIOPAK
| Applicant | Bioware Products, Walker MI, US |
| Decision | Substantially Equivalent, Dec 1, 1980 |
| Received | Sep 23, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802308
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.