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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 K955355
Device Name VARIANT ALPHA-THALASSEMIA SHORT PROGRAM
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact KENNETH J KISCO
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact KENNETH J KISCO
Regulation Number864.7415
Classification Product Code
GKA  
Subsequent Product Code
LGL  
Date Received11/21/1995
Decision Date 04/26/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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