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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K101456
Device Name ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
Applicant
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact Susan Hollandbeck
Correspondent
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact Susan Hollandbeck
Regulation Number862.1150
Classification Product Code
JIX  
Subsequent Product Code
JIT  
Date Received05/26/2010
Decision Date 09/08/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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