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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 K946192
Device Name HICHEM Y-GT REAGENT KIT
Applicant
Hichem Diagnostics
231 N. Puente St.
Brea,  CA  92821
Applicant Contact WYNN STOCKING
Correspondent
Hichem Diagnostics
231 N. Puente St.
Brea,  CA  92821
Correspondent Contact WYNN STOCKING
Regulation Number862.1360
Classification Product Code
JQB  
Date Received12/20/1994
Decision Date 05/02/1995
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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