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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K100304
Device Name ST AIA PACK HBA1C
Applicant
Tosoh Bioscience, Inc.
6000 Shoreline Court, Suite 101
South San Franciso,  CA  94080
Applicant Contact Judith Ogden
Correspondent
Tosoh Bioscience, Inc.
6000 Shoreline Court, Suite 101
South San Franciso,  CA  94080
Correspondent Contact Judith Ogden
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Codes
JIT   JJY  
Date Received02/03/2010
Decision Date 08/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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