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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Gamma-Glutamyl Transpeptidase
510(k) Number K020486
Device Name CARESIDE GGT
Applicant
Careside, Inc.
6100 Bristol Pkwy.
Culver City,  CA  90230
Applicant Contact KENNETH B ASARCH
Correspondent
Careside, Inc.
6100 Bristol Pkwy.
Culver City,  CA  90230
Correspondent Contact KENNETH B ASARCH
Regulation Number862.1360
Classification Product Code
JPZ  
Date Received02/13/2002
Decision Date 07/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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