510(k) K840458 ยท JJY Multi-Analyte Controls, All Kinds (Assayed)
BIOTIS ABNORMAL CLINICAL CHEM SERUM-
| Applicant | Otisville Biotech, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 17, 1984 |
| Received | Feb 2, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840458
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.