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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 K905618
Device Name GGT REAGENT
Applicant
Amresco, Inc.
30175 Solon Industrial Pkwy.
Solon,  OH  44139
Applicant Contact LEONARD SZYMKOWSKI
Correspondent
Amresco, Inc.
30175 Solon Industrial Pkwy.
Solon,  OH  44139
Correspondent Contact LEONARD SZYMKOWSKI
Regulation Number862.1360
Classification Product Code
JPZ  
Date Received12/14/1990
Decision Date 02/26/1991
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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