Alfa Wassermann Diagnostic Technologies, Inc. · Class I · Cleared Jul 3, 2012
| K-number | K113262 |
| Device name | ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT |
| Applicant | Alfa Wassermann Diagnostic Technologies, Inc. |
| Product code | CHH |
| Device class | Class I |
| Decision date | Jul 3, 2012 |
| Decision | Substantially Equivalent |
| Regulation | 862.1175 |
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