510(k) K853978 ยท CIX Bromcresol Green Dye-Binding, Albumin
TDX AMYLASE
| Applicant | Abbott Laboratories, Abbott Park IL, US |
| Decision | Substantially Equivalent, Oct 15, 1985 |
| Received | Sep 26, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853978
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.