510(k) K802997 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
HDL-CHOLESTEROL CONTROL SERUM
| Applicant | Isolab, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Dec 22, 1980 |
| Received | Nov 25, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802997
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.