Thermo Electron OY

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K063145PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLSOctober 17, 2007
K063705LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NOROctober 9, 2007
K063131CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLSOctober 5, 2007
K063838LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGHSeptember 27, 2007
K063086TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLSAugust 8, 2007
K061412THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401March 23, 2007
K063209HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMALMarch 21, 2007
K063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROLMarch 19, 2007
K063647CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGHMarch 12, 2007
K061107DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247August 8, 2006