510(k) K895555 ยท CJA Amyloclastic, Amylase
MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
| Applicant | Hichem Diagnostics, Brea CA, US |
| Decision | Substantially Equivalent, Dec 22, 1989 |
| Received | Sep 6, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K895555
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.