Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software— 510(k) K171664
Substantially EquivalentBio-Rad Laboratories, Inc.
FDA 510(k) clearance K171664 for Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software, Substantially Equivalent on 2017-09-13. Applicant: Bio-Rad Laboratories, Inc..
Clearance details
- Applicant
- Bio-Rad Laboratories, Inc.
- Product code
- Code GKA
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Hercules, CA, US
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