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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 K062319
Device Name CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
Applicant
Roche Diagnostics Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250 -0457
Applicant Contact CORINA HARPER
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd., P.O. Box 50457
Indianapolis,  IN  46250 -0457
Correspondent Contact CORINA HARPER
Regulation Number862.1150
Classification Product Code
JIX  
Date Received08/09/2006
Decision Date 09/13/2006
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
Predetermined Change
Control Plan Authorized		 No
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