510(k) K981328 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT
| Applicant | Inova Diagnostics, Inc., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 19, 1998 |
| Received | Apr 13, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981328
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.