Alfa Wassermann Diagnostic Technologies, Inc. · Class II · Cleared Aug 10, 2012
| K-number | K113389 |
| Device name | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT |
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc. |
| Product code | CDN |
| Device class | Class II |
| Decision date | Aug 10, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 862.1770 |
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