Thermo Electron OY
Medical device manufacturer in Vantaa, FI.
14510(k) clearances
0PMA approvals
0recalls
Device types
- KQN Radioassay, Angiotensin Converting Enzyme 1
- CFR Hexokinase, Glucose 1
- JJY Multi-Analyte Controls, All Kinds (Assayed) 1
- CEM Electrode, Ion Specific, Potassium 1
- NDY Test, Cystatin C 1
- JIT Calibrator, Secondary 1
- CZW Complement C3, Antigen, Antiserum, Control 1
- LCP Assay, Glycosylated Hemoglobin 1
- JFY Enzymatic Method, Creatinine 1
- DDG Transferrin, Antigen, Antiserum, Control 1
- DFC Lipoprotein, Low-Density, Antigen… 1
- KLT Enzyme Immunoassay, Carbamazepine 1
- NDW Assay, Porphyrin, Spectrophotometry, Lithium 1
- DIP Enzyme Immunoassay, Diphenylhydantoin 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K063145 | Phenobarbital, Phenytoin, TDM Calibration Set B and Abtrol/Nortrol ControlsDIP · Traditional | 10/17/2007SE |
| K063705 | Lithium Micro Volume Electrode, Theophylline, Ise Calibrators 1, 2 and 3, TDM…NDW · Traditional | 10/09/2007SE |
| K063131 | Carbamazepine, Valproic Acid, TDM Calibration Set B and Abtrol, Nortrol ControlsKLT · Traditional | 10/05/2007SE |
| K063838 | Lipoprotein(A), Lipoprotein(A) Calibrator, Lipoprotein (a) Control, Control HighDFC · Traditional | 09/27/2007SE |
| K063086 | Transferrin, Specical Calibrator, Specitrol and Specitrol High ControlsDDG · Traditional | 08/08/2007SE |
| K061412 | Thermo Electron Enzymatic Creatinine, Model TR35401JFY · Traditional | 03/23/2007SE |
| K063209 | HBA1C; Calibrator; Control Normal, Control AbnormalLCP · Traditional | 03/21/2007SE |
| K063150 | Complement C3 and C4, Specical Calibrator and Specitrol Control and High ControlCZW · Traditional | 03/19/2007SE |
| K062521 | Oxalate Urine Controls (Normal and Elevated)JIT · Traditional | 03/16/2007SE |
| K063647 | Cystatin C Antiserum, Calibrator, Control and Control HighNDY · Traditional | 03/12/2007SE |
| K061107 | DPC T60I Kusti, Model 984248; DPC T60I, Model 984247CEM · Traditional | 08/08/2006SE |
| K052056 | Data-Trol N Normal Control Serum, Data-Trol a Abnormal Control SerumJJY · Traditional | 09/23/2005SE |
| K042767 | Datapro Clinical Chelistry AnalyzerCFR · Traditional | 04/27/2005SE |
| K041657 | Thermo Electron Angiotensin Converting Enzyme Infinity (Ace) ReagentKQN · Traditional | 08/30/2004SE |