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FDA 510(k) Application Details - K972167
Device Classification Name
Chromatographic/Fluorometric Method, Catecholamines
More FDA Info for this Device
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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More FDA Info for this Product Code
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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