510(k) K973822 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
VIRGO ANCA SCREEN KIT
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Nov 13, 1997 |
| Received | Oct 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K973822
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.