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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 K122242
Model K101365
Device Name ELECSYS CA 15-3 II CALCHECK 5
Applicant
ROCHE DIAGNOSTICS
9115 hague road
indianapolis,  IN  46250 0416
Contact edie eads
Regulation Number862.1660
Classification Product Code
JJX  
Date Received07/27/2012
Decision Date 12/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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