510(k) K041043 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
| Applicant | Pharmacia Deutschland GmbH, Freiburg Im Breisgau, DE |
| Decision | Substantially Equivalent, Jul 2, 2004 |
| Received | Apr 22, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041043
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.