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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
Recalls CDRH Recalls
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