510(k) K001569 ยท JFJ Catalytic Methods, Amylase
INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)
| Applicant | Sigma Diagnostics, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Jun 26, 2000 |
| Received | May 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001569
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.