Medical Device Manufacturer · FI , Vantaa

Thermo Electron OY

9 submissions · 9 cleared · Since 2006
9
Total
9
Cleared
0
Denied

Thermo Electron OY — FDA 510(k) Submissions

Thermo Electron OY has submitted 9 FDA 510(k) premarket notifications since 2006, of which 9 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrode, Ion Specific, Potassium, Transferrin, Antigen, Antiserum, Control, Enzyme Immunoassay, Carbamazepine, Enzyme Immunoassay, Diphenylhydantoin, Complement C3, Antigen, Antiserum, Control . Use the specialty filter in the sidebar to narrow results.

9 devices
1–9 of 9
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS
K063145 · DIP Enzyme Immunoassay,... · Toxicology
Oct 2007 366d
LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL
K063705 · NDW Assay, Porphyrin,... · Toxicology
Oct 2007 300d
CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS
K063131 · KLT Enzyme Immunoassay,... · Toxicology
Oct 2007 357d
LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH
K063838 · DFC Lipoprotein, Low-density,... · Chemistry
Sep 2007 275d
TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS
K063086 · DDG Transferrin, Antigen,... · Immunology
Aug 2007 302d
HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL
K063209 · LCP Assay, Glycosylated... · Chemistry
Mar 2007 149d
COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL
K063150 · CZW Complement C3, Antigen,... · Immunology
Mar 2007 154d
CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH
K063647 · NDY Test, Cystatin C · Chemistry
Mar 2007 95d
DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247
K061107 · CEM Electrode, Ion Specific,... · Chemistry
Aug 2006 110d
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