510(k) K013978 ยท JFJ Catalytic Methods, Amylase
SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Jan 15, 2002 |
| Received | Dec 3, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K013978
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.