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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 K871979
Device Name GAMMA GLUTAMYLTRANSFERASE REAGENT
Applicant
Intersect Systems, Inc.
1606 E. Kessler Blvd., #100
P.O. Box 889
Longview,  WA  98632
Applicant Contact LESTER B GARRISON
Correspondent
Intersect Systems, Inc.
1606 E. Kessler Blvd., #100
P.O. Box 889
Longview,  WA  98632
Correspondent Contact LESTER B GARRISON
Regulation Number862.1360
Classification Product Code
JPZ  
Date Received05/22/1987
Decision Date 06/11/1987
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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