510(k) K800115 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
DURAZYME GPT/ALT
| Applicant | American Monitor Corp., Mchenry IL, US |
| Decision | Substantially Equivalent, Feb 13, 1980 |
| Received | Jan 18, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800115
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.