510(k) K974702 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
ORGENTEC ANTI-PR3 (C-ANCA) ELISA
| Applicant | American Laboratory Products Co., Ltd., Windham NH, US |
| Decision | Substantially Equivalent, Feb 17, 1998 |
| Received | Dec 8, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974702
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.