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Thermo Electron OY

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K063145 PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSDIP2007-10-17 View
510(k) K063705 LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROLNDW2007-10-09 View
510(k) K063131 CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLSKLT2007-10-05 View
510(k) K063838 LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGHDFC2007-09-27 View
510(k) K063086 TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLSDDG2007-08-08 View
510(k) K063209 HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMALLCP2007-03-21 View
510(k) K063150 COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROLCZW2007-03-19 View
510(k) K063647 CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGHNDY2007-03-12 View
510(k) K061107 DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247CEM2006-08-08 View
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