510(k) K023396 ยท CIJ Saccharogenic, Amylase
AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
| Applicant | Pointe Scientific, Inc.,, Lincoln Park MI, US |
| Decision | Substantially Equivalent, Dec 23, 2002 |
| Received | Oct 9, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023396
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.