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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, secondary
510(k) Number K140112
Device Name CA 125 II CALSET II
Original Applicant
Roche Diagnostics
9155 hague rd.
po box 50416
indianapolis,  IN  46250
Original Contact jane ellen phillips
Regulation Number862.1150
Classification Product Code
Date Received01/15/2014
Decision Date 06/06/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No