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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test, Cystatin C
510(k) Number K093960
Device Name ST AIA-PACK CYSTATIN C, MODEL 025217
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 Number862.1225
Classification Product Code
NDY  
Subsequent Product Code
JIT  
Date Received12/23/2009
Decision Date 09/14/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
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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