Genzyme Diagnostics P.E.I., Inc. · Class II · Cleared May 1, 2009
| K-number | K081938 |
| Device name | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 |
| Applicant | Genzyme Diagnostics P.E.I., Inc. |
| Product code | LDP |
| Device class | Class II |
| Decision date | May 1, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 862.3030 |
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