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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 K890312
Device Name GAMMA-GLUTAMYLTRANSFERASE
Applicant
American Monitor Corp.
P.O. Box 68505
Indianapolis,  IN  46268
Applicant Contact MARCIA J ARENTZ
Correspondent
American Monitor Corp.
P.O. Box 68505
Indianapolis,  IN  46268
Correspondent Contact MARCIA J ARENTZ
Regulation Number862.1360
Classification Product Code
JQB  
Date Received01/23/1989
Decision Date 03/24/1989
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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