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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 K070200
Device Name TDM CONTROL SET, MODEL CAT# 04521536
Applicant
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolos,  IN  46250
Applicant Contact DIMITRIS DEMIRTZOGLOU
Correspondent
Roche Diagnostics Corp.
9115 Hague Rd.
Indianapolos,  IN  46250
Correspondent Contact DIMITRIS DEMIRTZOGLOU
Regulation Number862.1660
Classification Product Code
JJY  
Date Received01/22/2007
Decision Date 03/19/2007
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
Predetermined Change
Control Plan Authorized		 No
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