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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K113177
Model 1291-31/1292-31
Device Name COMPLETE D 25-OH VITAMIN D CONTROL
Original Applicant
QUANTIMETRIX CORP.
2005 manhattan beach blvd.
redondo beach,  CA  90278 1205
Original Contact kalyna snylyk
Regulation Number862.1660
Classification Product Code
JJX  
Date Received10/28/2011
Decision Date 05/10/2012
Decision substantially equivalent (SE)
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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