Home / 510(k) Clearances / K171664

510(k) K171664

Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software by Bio-Rad Laboratories, Inc. — Product Code GKA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2017
Date Received
June 5, 2017
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Abnormal Hemoglobin Quantitation
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

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