FDA 510(k) Application Details - K112161

Device Classification Name	Fluorometer, For Clinical Use   More FDA Info for this Device
510(K) Number	K112161
Device Name	Fluorometer, For Clinical Use
Applicant	RADIOMETER MEDICAL APS AAKANDEVEJ 21 BRONSHOJ DK-2700 DK Other 510(k) Applications for this Company
Contact	JANA S HELLMANN Other 510(k) Applications for this Contact
Regulation Number	862.2560   More FDA Info for this Regulation Number
Classification Product Code	KHO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/27/2011
Decision Date	01/20/2012
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