510(k) K123018 ยท CFR Hexokinase, Glucose
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, Apr 23, 2013 |
| Received | Sep 28, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123018
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.