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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
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