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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mercuric Thiocyanate, Colorimetry, Chloride
510(k) Number K911297
Device Name CHLORIDE 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 Number862.1170
Classification Product Code
CHJ  
Date Received03/25/1991
Decision Date 04/16/1991
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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