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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 K101365
Device Name ELECSYS CA 19-9 CALCHECK 5
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis,  IN  46250 -0457
Applicant Contact KELLY O'MAINE ADAMS
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
P.O. Box 50416
Indianapolis,  IN  46250 -0457
Correspondent Contact KELLY O'MAINE ADAMS
Regulation Number862.1660
Classification Product Code
JJX  
Date Received05/17/2010
Decision Date 10/05/2010
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
Predetermined Change
Control Plan Authorized		 No
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