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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 K842104
Device Name TOYO JOZO G-GTP TEST
Applicant
Advocacy International, Ltd.
1825 Eye St. NW, Suite 400
Washington,  DC  20006
Applicant Contact RICHARD T NEY
Correspondent
Advocacy International, Ltd.
1825 Eye St. NW, Suite 400
Washington,  DC  20006
Correspondent Contact RICHARD T NEY
Regulation Number862.1360
Classification Product Code
JPZ  
Date Received05/25/1984
Decision Date 08/10/1984
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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