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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Porphyrin, Spectrophotometry, Lithium
510(k) Number K063705
Device Name LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
Applicant
Thermo Electron OY
Ratastie 2
P.O. Box 100
Vantaa,  FI FIN-01621
Applicant Contact PAIVI SORMUNEN
Correspondent
Thermo Electron OY
Ratastie 2
P.O. Box 100
Vantaa,  FI FIN-01621
Correspondent Contact PAIVI SORMUNEN
Regulation Number862.3560
Classification Product Code
NDW  
Subsequent Product Codes
DKB   JIX   KLS  
Date Received12/13/2006
Decision Date 10/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
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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