510(k) K971039 ยท MID System, Test, Anticardiolipin Immunological
HEMAGEN ANTI CARDIOLIPIN SCREEN
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Jun 3, 1997 |
| Received | Mar 21, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971039
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.