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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biuret (Colorimetric), Total Protein
510(k) Number K913225
Device Name URINE/CSF MICROPROTEIN REAGENT
Applicant
Intersect Systems, Inc.
1152 3rd Ave., Suite D/E
P.O. Box 2219
Longview,  WA  98632
Applicant Contact MARK E LEGAZ
Correspondent
Intersect Systems, Inc.
1152 3rd Ave., Suite D/E
P.O. Box 2219
Longview,  WA  98632
Correspondent Contact MARK E LEGAZ
Regulation Number862.1635
Classification Product Code
CEK  
Date Received07/19/1991
Decision Date 10/11/1991
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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