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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urinary Carbohydrate Analysis Kit
510(k) Number K945519
Device Name FACE (FLUOROPHORE-ASSISTED-CARBOHYDRATE-ELECTROPHORESIS) URINARY CARBOHYDRATE ANALYSIS SYSTEM
Applicant
Pharmaquest Corp.
4470 Redwood High Way
Suite 101
San Rafael,  CA  94903
Applicant Contact RICHARD J D'AGOSTINO
Correspondent
Pharmaquest Corp.
4470 Redwood High Way
Suite 101
San Rafael,  CA  94903
Correspondent Contact RICHARD J D'AGOSTINO
Regulation Number862.1505
Classification Product Code
MPG  
Date Received11/09/1994
Decision Date 11/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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