510(k) K924857 ยท DHX System, Test, Carcinoembryonic Antigen
AIA-PACK CEA CALIBRATION VERIFICATION TEST SET
| Applicant | Tosoh Medics, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Mar 18, 1993 |
| Received | Sep 28, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K924857
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.