510(k) K941840 ยท MID System, Test, Anticardiolipin Immunological
HEMAGEN ACL IGA CALIBRATOR
| Applicant | Hemagen Diagnostics, Inc., Waltham MA, US |
| Decision | Substantially Equivalent, Jun 30, 1994 |
| Received | Apr 13, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941840
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.