510(k) K904768 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
KODATROL I AND II CONTROL AND DILUENT SET
| Applicant | Eastman Kodak Company, Rochester NY, US |
| Decision | Substantially Equivalent, Nov 9, 1990 |
| Received | Oct 22, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K904768
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 16, 2020 | Ortho Clinical Diagnostics Inc VITROS Chemistry Products Performance Verifier II-For in vitro diagnostic use only.VITROS Chemistry Products Performance Verifier is an assayed control used to monitor performance on VITROS 250/350/5, Open, Classified |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.