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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Abnormal Hemoglobin Quantitation
510(k) Number K171664
Device Name Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
Applicant
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact Sweta Patel
Correspondent
Bio-Rad Laboratories, Inc.
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact Sweta Patel
Regulation Number864.7415
Classification Product Code
GKA  
Date Received06/05/2017
Decision Date 09/13/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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