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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K111762
Device Name ST AIA-PACK DHEA-S CALIBRATOR SET
Applicant
Tosoh Bioscience, Inc.
6000 Shoreline Ct., Suite 101
South San Franciso,  CA  94080
Applicant Contact JUDITH K OGDEN
Correspondent
Tosoh Bioscience, Inc.
6000 Shoreline Ct., Suite 101
South San Franciso,  CA  94080
Correspondent Contact JUDITH K OGDEN
Regulation Number862.1150
Classification Product Code
JIT  
Date Received06/23/2011
Decision Date 08/05/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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