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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 K052056
Device Name DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM
Applicant
Thermo-Electron Corp.
189-199 Browns Rd.
Noble Park,  AU 3174
Applicant Contact MELITA LAMBIRIS
Correspondent
Thermo-Electron Corp.
189-199 Browns Rd.
Noble Park,  AU 3174
Correspondent Contact MELITA LAMBIRIS
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/29/2005
Decision Date 09/23/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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