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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K062521
Device Name OXALATE URINE CONTROLS (NORMAL AND ELEVATED)
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 Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
JJW  
Date Received08/28/2006
Decision Date 03/16/2007
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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