510(k) K862370 ยท CIJ Saccharogenic, Amylase
DART AMYLASE-D.S. REAGENT SYSTEM
| Applicant | Coulter Electronics, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Aug 1, 1986 |
| Received | Jun 24, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862370
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.