Alfa Wassermann Diagnostic Technologies, Inc. · Class I · Cleared May 17, 2012
| K-number | K113253 |
| Device name | ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT |
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc. |
| Product code | JJE |
| Device class | Class I |
| Decision date | May 17, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 862.2160 |
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