Alfa Wassermann, Inc. · Class II · Cleared Apr 17, 2007
| K-number | K063306 |
| Device name | ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 |
| Applicant | Alfa Wassermann, Inc. |
| Product code | LCP |
| Device class | Class II |
| Decision date | Apr 17, 2007 |
| Decision | Substantially Equivalent |
| Regulation | 864.7470 |
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