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FDA 510(k) Application Details - K113521
Device Classification Name
Titrimetric With Edta And Indicator, Calcium
More FDA Info for this Device
510(K) Number
K113521
Device Name
Titrimetric With Edta And Indicator, Calcium
Applicant
Roche Diagnostics
9115 HAGUE ROAD
INDIANAPOLIS, IN 46250-0416 US
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Contact
LISA K KLINEDINST
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Regulation Number
862.1145
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Classification Product Code
CHW
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More FDA Info for this Product Code
Date Received
11/29/2011
Decision Date
05/08/2012
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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