510(k) K080823 ยท JFJ Catalytic Methods, Amylase
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
| Applicant | Medica Corp., Bedford MA, US |
| Decision | Substantially Equivalent, Nov 17, 2008 |
| Received | Mar 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080823
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.