510(k) K992449 ยท MID System, Test, Anticardiolipin Immunological
AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA
| Applicant | Cogent Diagnotics , Ltd., Midlothian, Scotland, GB |
| Decision | Substantially Equivalent, Nov 24, 1999 |
| Received | Jul 22, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992449
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.