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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ldl & Vldl Precipitation, Hdl
510(k) Number K934039
Device Name INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET
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 Number862.1475
Classification Product Code
LBR  
Date Received08/18/1993
Decision Date 11/16/1993
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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