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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K932888
Device Name INTERSECT SYSTEMS DIRECT AMYLASE 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 Number862.1070
Classification Product Code
JFJ  
Date Received06/14/1993
Decision Date 01/31/1994
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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