510(k) K821882 ยท CKA Nadh Oxidation/Nad Reduction, Alt/Sgpt
ULTRAZYME PLUS GPT
| Applicant | Harleco Diagnostics, Mchenry IL, US |
| Decision | Substantially Equivalent, Jul 14, 1982 |
| Received | Jun 25, 1982 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K821882
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.