510(k) K123977 ยท CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR
| Applicant | Randox Laboratories, Ltd., Crumlin, GB |
| Decision | Substantially Equivalent, Nov 21, 2013 |
| Received | Dec 26, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123977
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.