510(k) K812699 ยท KHM Nephelometric, Amylase
AMYLASE
| Applicant | Pointe Scientific, Inc.,, Mchenry IL, US |
| Decision | Substantially Equivalent, Oct 6, 1981 |
| Received | Sep 22, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K812699
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.