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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatographic/Fluorometric Method, Catecholamines
510(k) Number K943099
Device Name URINARY CATECHOLAMINE KIT
Applicant
Bioanalytical Systems, Inc.
2701 Kent Ave.
West Lafayette,  IN  47906
Applicant Contact STEPHEN GEARY
Correspondent
Bioanalytical Systems, Inc.
2701 Kent Ave.
West Lafayette,  IN  47906
Correspondent Contact STEPHEN GEARY
Regulation Number862.1165
Classification Product Code
CHQ  
Date Received06/29/1994
Decision Date 10/07/1994
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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