510(k) K091846 ยท JFJ Catalytic Methods, Amylase
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Oct 16, 2009 |
| Received | Jun 22, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091846
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.