510(k) K993085 ยท MID System, Test, Anticardiolipin Immunological
AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA
| Applicant | Cogent Diagnotics , Ltd., Garden Grove CA, US |
| Decision | Substantially Equivalent, Feb 1, 2000 |
| Received | Sep 15, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993085
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.