510(k) K932768 ยท JIX Calibrator, Multi-Analyte Mixture
CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323
| Applicant | Helena Laboratories, Beaumont TX, US |
| Decision | Substantially Equivalent, Oct 18, 1993 |
| Received | Jun 8, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K932768
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.