510(k) K860530 ยท CJA Amyloclastic, Amylase
AMYLASE REAGENT SET (MODIFIED CARAWAY)
| Applicant | Sterling Diagnostics, Inc., Sterling Heights MI, US |
| Decision | Substantially Equivalent, Feb 28, 1986 |
| Received | Feb 12, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860530
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.