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FDA 510(k) Application Details - K123660
Device Classification Name
System, Test, Vitamin D
More FDA Info for this Device
510(K) Number
K123660
Device Name
System, Test, Vitamin D
Applicant
EUROIMMUN US
1100 THE AMERICAN ROAD
MORRIS PLAINS, NJ 07950 US
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Contact
KATHRYN KOHL
Other 510(k) Applications for this Contact
Regulation Number
862.1825
More FDA Info for this Regulation Number
Classification Product Code
MRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/28/2012
Decision Date
07/17/2013
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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