510(k) K954105 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
| Applicant | Scimedx Corp., Denvill NJ, US |
| Decision | Substantially Equivalent, Mar 19, 1996 |
| Received | Aug 31, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954105
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.