510(k) K991942 ยท MLE Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA
| Applicant | Cogent Diagnotics , Ltd., Midlothian, Scotland, GB |
| Decision | Substantially Equivalent, Aug 24, 1999 |
| Received | Jun 9, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991942
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.