510(k) K950590 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
REP CHOLESTEROL PROFILE CONTROL
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Mar 30, 1995 |
| Received | Feb 9, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950590
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.