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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
510(k) Number K941807
Device Name INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT
Applicant
Intersect Systems, Inc.
1152 3rd Ave., Suite D/E
P.O. Box 2219
Longview,  WA  98632
Applicant Contact TARAS TATARKO
Correspondent
Intersect Systems, Inc.
1152 3rd Ave., Suite D/E
P.O. Box 2219
Longview,  WA  98632
Correspondent Contact TARAS TATARKO
Regulation Number862.1170
Classification Product Code
CHG  
Date Received04/12/1994
Decision Date 09/14/1994
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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