510(k) K061376 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
| Applicant | Theratest Laboratories, Inc., Lombard IL, US |
| Decision | Substantially Equivalent, Jul 20, 2006 |
| Received | May 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061376
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.