510(k) K123953 ยท KHS Enzymatic, Carbon-Dioxide
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc., West Caldwell NJ, US |
| Decision | Substantially Equivalent, May 2, 2013 |
| Received | Dec 21, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123953
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.