Device Listing 1980146540
Listing Summary#
- Listing key
- 1980146540
- Premarket submission
- K171664
- Device
- Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- GKA
- Decision date
- 2017-09-13