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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name titrimetric with edta and indicator, calcium
510(K) Number K113521
Device Name CALCIUM GEN. 2
Applicant
ROCHE DIAGNOSTICS
9115 hague road
indianapolis,  IN  46250 0416
Contact lisa k klinedinst
Regulation Number862.1145
Classification Product Code
CHW  
Date Received11/29/2011
Decision Date 05/08/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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