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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K102016
Device Name PRECICONTROL CLINCHEM MULTI 1 AND 2
Applicant
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Applicant Contact PATRICK J STIMART
Correspondent
Roche Diagnostics
9115 Hague Road
Indianapolis,  IN  46250
Correspondent Contact PATRICK J STIMART
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/19/2010
Decision Date 09/01/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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