510(k) K800035 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
PENTEX LIPOPROTEIN CHOLESTEROL SOLU.
| Applicant | Miles Laboratories, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 21, 1980 |
| Received | Jan 7, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800035
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.