K171664

Substantially Equivalent

Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software

Applicant: Bio-Rad Laboratories, Inc.
Product code: GKA
Advisory panel: Hematology
Date received: 2017-06-05
Decision date: 2017-09-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Hercules, CA, US

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