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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
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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
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