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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 K924122
Device Name VARIANT BETA-THALASSEMIA SHORT PROGRAM
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547 -1803
Applicant Contact JEFFREY S BAUER
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547 -1803
Correspondent Contact JEFFREY S BAUER
Regulation Number864.7400
Classification Product Code
JPD  
Date Received08/14/1992
Decision Date 03/11/1993
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
Recalls CDRH Recalls
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