DPC T60I Kusti, Model 984248; DPC T60I, Model 984247
FDA 510(k) K061107 · Thermo Electron OY
510(k) numberK061107
Submission
- Device name
- DPC T60I Kusti, Model 984248; DPC T60I, Model 984247
- Applicant
- Thermo Electron OY
Vantaa, FI - Received
- April 20, 2006
- Decision date
- August 8, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CEM – Electrode, Ion Specific, Potassium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | Roche Diagnostics | 02/12/2026SE |
| K241037 | ABL90 FLEX PLUS SystemCEM · Traditional | Radiometer Medicals Aps | 01/14/2025SE |
| K220396 | EasyStat 300CEM · Traditional | Medica Corporation | 09/26/2023SE |
| K230890 | ISE ElectrodesCEM · Special | Randox Laboratories, Ltd. | 09/08/2023SE |
| K200544 | SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+CEM · Traditional | Diamond Diagnostics, Inc. | 10/01/2020SE |
| K121012 | Flexlab 3.6, Accelerator A3600CEM · Traditional | Inpeco S.P.A. | 08/31/2012SE |
| K121040 | Smartlyte Electrolyte AnalyzerCEM · Traditional | Diamond Diagnostics, Inc. | 08/30/2012SE |
| K112995 | Gem Premier 4000CEM · Traditional | Instrumentation Laboratory CO | 05/03/2012SE |
| K110520 | Biolis 12ICEM · Traditional | Tokyo Boeki Medisys, Inc. | 03/23/2012SE |
| K112412 | AU5800(R) Chemistry AnalyzerCEM · Traditional | Beckman Coulter, Inc. | 12/23/2011SE |
More from Beckman Coulter, Inc.
| 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 |
Questions and answers
When was DPC T60I Kusti, Model 984248; DPC T60I, Model 984247 cleared by the FDA?
DPC T60I Kusti, Model 984248; DPC T60I, Model 984247 (K061107) received a 510(k) decision of Substantially Equivalent on August 8, 2006, 110 days after the submission was received.
What is the product code of K061107?
The FDA product code is CEM – Electrode, Ion Specific, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.