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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 K901264
Device Name COULTER GAMMA-GT (GGT) REAGENT
Applicant
Coulter Corp.
745 W. 83rd St.
Hialeah,  FL  33014
Applicant Contact A RICHARDSON-JONES
Correspondent
Coulter Corp.
745 W. 83rd St.
Hialeah,  FL  33014
Correspondent Contact A RICHARDSON-JONES
Regulation Number862.1360
Classification Product Code
JQB  
Date Received03/16/1990
Decision Date 04/16/1990
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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