510(k) K974053 ยท JFJ Catalytic Methods, Amylase
AMYLASE-SL ASSAY CATALOGUE NUMBER 341-10
| Applicant | Diagnostic Chemicals , Ltd., Charlottestown,Pei,Canada, CA |
| Decision | Substantially Equivalent, Dec 8, 1997 |
| Received | Oct 27, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974053
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.