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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 K071132
Device Name G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
Applicant
Tosoh Bioscience, Inc.
6000 Shoreline Court, Suite 101
South San Franciso,  CA  94080
Applicant Contact CHARLES P GILL
Correspondent
Tosoh Bioscience, Inc.
6000 Shoreline Court, Suite 101
South San Franciso,  CA  94080
Correspondent Contact CHARLES P GILL
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JIS  
Date Received04/23/2007
Decision Date 09/16/2008
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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