Alfa Wassermann Diagnostic Technologies, Inc. · Class II · Cleared May 2, 2013
| K-number | K123953 |
| Device name | ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT |
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc. |
| Product code | KHS |
| Device class | Class II |
| Decision date | May 2, 2013 |
| Decision | Substantially Equivalent |
| Regulation | 862.1160 |
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