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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kinetic Method, Gamma-Glutamyl Transpeptidase
510(k) Number K971466
Device Name SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)
Applicant
Carolina Liquid Chemistries Corp.
451 W. Lambert Rd.,
Suite 207
Brea,  CA  92821
Applicant Contact CYNTHIA SHUGART
Correspondent
Carolina Liquid Chemistries Corp.
451 W. Lambert Rd.,
Suite 207
Brea,  CA  92821
Correspondent Contact CYNTHIA SHUGART
Regulation Number862.1360
Classification Product Code
JQB  
Date Received04/22/1997
Decision Date 05/06/1997
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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