510(k) K122858 ยท JFJ Catalytic Methods, Amylase
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
| Applicant | Elitechgroup, Bothell WA, US |
| Decision | Substantially Equivalent, Oct 3, 2012 |
| Received | Sep 18, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122858
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.