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FDA 510(k) Application Details - K152227
Device Classification Name
Fluorometric, Cortisol
More FDA Info for this Device
510(K) Number
K152227
Device Name
Fluorometric, Cortisol
Applicant
ROCHE DIAGNOSTICS
9115 HAGUE ROAD
INDIANAPOLIS, IN 46250 US
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Contact
KELLI TURNER
Other 510(k) Applications for this Contact
Regulation Number
862.1205
More FDA Info for this Regulation Number
Classification Product Code
JFT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/07/2015
Decision Date
04/27/2016
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
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