510(k) K950801 ยท JJT Enzyme Controls (Assayed And Unassayed)
CARDIO REP LD CONTROL - CAT NO. 3325
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Mar 30, 1995 |
| Received | Feb 21, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950801
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.