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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemoglobin A2 Quantitation
510(k) Number K875102
Device Name DETER. OF HEMOGLOBIN A2 USING THE DIAMAT
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact FRANK MATARRESE
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact FRANK MATARRESE
Regulation Number864.7400
Classification Product Code
JPD  
Date Received12/10/1987
Decision Date 02/24/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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