510(k) K812594 ยท CIJ Saccharogenic, Amylase
ULTRA ZYME PLUS AMYL #64982 & 65031
| Applicant | Harleco, Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 2, 1981 |
| Received | Sep 11, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812594
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.