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FDA 510(k) Application Details - K162840
Device Classification Name
System, Test, Vitamin D
More FDA Info for this Device
510(K) Number
K162840
Device Name
System, Test, Vitamin D
Applicant
Roche Diagnostics
9115 Hague Road
Indianapolis, IN 46250 US
Other 510(k) Applications for this Company
Contact
Linda McCammack
Other 510(k) Applications for this Contact
Regulation Number
862.1825
More FDA Info for this Regulation Number
Classification Product Code
MRG
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More FDA Info for this Product Code
Date Received
10/11/2016
Decision Date
02/08/2017
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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