Device Listing 1635225387
Listing Summary#
- Listing key
- 1635225387
- Premarket submission
- K081938
- Device
- ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30
- Applicant
- Genzyme Diagnostics P.E.I., Inc.
- Product code
- LDP
- Decision date
- 2009-05-01