FDA 510(k) Applications Submitted by GENZYME DIAGNOSTICS P.E.I. INC.
| FDA 510(k) Number | Submission Date | Device Name | Applicant |
|---|---|---|---|
| K081938 | 07/08/2008 | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 | GENZYME DIAGNOSTICS P.E.I. INC. |
| K082210 | 08/06/2008 | TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 | GENZYME DIAGNOSTICS P.E.I. INC. |
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