FDA 510(k) Application Details - K972167

Device Classification Name Chromatographic/Fluorometric Method, Catecholamines

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510(K) Number K972167
Device Name Chromatographic/Fluorometric Method, Catecholamines
Applicant BIOANALYTICAL SYSTEMS, INC.
2701 KENT AVE.
WEST LAFAYETTE, IN 47906 US
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Contact STEPHEN GEARY
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Regulation Number 862.1165

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Classification Product Code CHQ
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Date Received 06/09/1997
Decision Date 08/04/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K972167


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