Company ยท FI
Thermo Electron OY
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2007. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CEM | Electrode, Ion Specific, Potassium | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CZW | Complement C3, Antigen, Antiserum, Control | 1 |
| DDG | Transferrin, Antigen, Antiserum, Control | 1 |
| DFC | Lipoprotein, Low-Density, Antigen, Antiserum, Control | 1 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | 1 |
| JFY | Enzymatic Method, Creatinine | 1 |
| JIT | Calibrator, Secondary | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| KLT | Enzyme Immunoassay, Carbamazepine | 1 |
| KQN | Radioassay, Angiotensin Converting Enzyme | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 |
| NDW | Assay, Porphyrin, Spectrophotometry, Lithium | 1 |
| NDY | Test, Cystatin C | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 17, 2007 | K063145 | PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS Thermo Electron OY, FI | DIP |
| Oct 9, 2007 | K063705 | LITHIUM MICRO VOLUME ELECTRODE, THEOPHYLLINE, ISE CALIBRATORS 1, 2 AND 3, TDM CALIBRATION SET B, NORTROL AND ABTROL Thermo Electron OY, FI | NDW |
| Oct 5, 2007 | K063131 | CARBAMAZEPINE, VALPROIC ACID, TDM CALIBRATION SET B AND ABTROL, NORTROL CONTROLS Thermo Electron OY, FI | KLT |
| Sep 27, 2007 | K063838 | LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH Thermo Electron OY, FI | DFC |
| Aug 8, 2007 | K063086 | TRANSFERRIN, SPECICAL CALIBRATOR, SPECITROL AND SPECITROL HIGH CONTROLS Thermo Electron OY, FI | DDG |
| Mar 23, 2007 | K061412 | THERMO ELECTRON ENZYMATIC CREATININE, MODEL TR35401 Thermo Electron Corp. | JFY |
| Mar 21, 2007 | K063209 | HBA1C; CALIBRATOR; CONTROL NORMAL, CONTROL ABNORMAL Thermo Electron OY, FI | LCP |
| Mar 19, 2007 | K063150 | COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL Thermo Electron OY, FI | CZW |
| Mar 16, 2007 | K062521 | OXALATE URINE CONTROLS (NORMAL AND ELEVATED) Thermo-Electron Corp., AU | JIT |
| Mar 12, 2007 | K063647 | CYSTATIN C ANTISERUM, CALIBRATOR, CONTROL AND CONTROL HIGH Thermo Electron OY, FI | NDY |
| Aug 8, 2006 | K061107 | DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247 Thermo Electron OY, FI | CEM |
| Sep 23, 2005 | K052056 | DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM Thermo-Electron Corp., AU | JJY |
| Apr 27, 2005 | K042767 | DATAPRO CLINICAL CHELISTRY ANALYZER Thermo Electron Corporation | CFR |
| Aug 30, 2004 | K041657 | THERMO ELECTRON ANGIOTENSIN CONVERTING ENZYME INFINITY (ACE) REAGENT Thermo Electron Corporation | KQN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||