Device Listing 1948916215
Listing Summary#
- Listing key
- 1948916215
- Premarket submission
- K160762
- Device
- Diazyme Direct HbA1c Assay (Enzymatic, On-Board Lysis), Diazyme Direct HbA1c Assay Calibrator Set, Diazyme Direct HbA1c Assay Control Set
- Applicant
- Diazyme Laboratories
- Product code
- LCP
- Decision date
- 2016-11-21