Genzyme Diagnostics P.E.I., Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K081938 | ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30 | May 1, 2009 |
| K082210 | TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 | December 16, 2008 |