Thermo Electron OY is one of 47 FDA 510(k) medical device manufacturers from Finland in the dataset, ranked by real submission volume.
Thermo Electron OY - FDA 510(k) Cleared Devices
Recent clearances: PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS, LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL, CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
9
Total
9
Cleared
0
Denied
Thermo Electron OY has 9 FDA 510(k) cleared medical devices. Based in Vantaa, FI.
Historical record: 9 cleared submissions from 2006 to 2007. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Thermo Electron OY Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Thermo Electron OY
9 devices
Cleared
Oct 17, 2007
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
Toxicology
366d
Cleared
Oct 09, 2007
LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM...
Toxicology
300d
Cleared
Oct 05, 2007
CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
Toxicology
357d
Cleared
Sep 27, 2007
LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
Chemistry
275d
Cleared
Aug 08, 2007
TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
Immunology
302d
Cleared
Mar 21, 2007
HBA1C
Chemistry
149d
Cleared
Mar 19, 2007
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
Immunology
154d
Cleared
Mar 12, 2007
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
Chemistry
95d
Cleared
Aug 08, 2006
DPC T60I KUSTI, MODEL 984248
Chemistry
110d