Thermo Dma Data-Cal Calibrator, Model 1905-050
FDA 510(k) K022108 · Thermo Dma, Inc.
510(k) numberK022108
Submission
- Device name
- Thermo Dma Data-Cal Calibrator, Model 1905-050
- Applicant
- Thermo Dma, Inc.
Arlington, TX, US - Received
- June 28, 2002
- Decision date
- July 25, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIX – Calibrator, Multi-Analyte Mixture
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex…JIX · Traditional | Siemens Healthcare Diagnostics | 06/15/2015SE |
| K141388 | System CalibraterJIX · Abbreviated | Beckman Coulter Ireland, Inc. | 07/11/2014SE |
| K133330 | C.F.A.S. Proteins, C.F.A.S. Pac, Precicontrol Clinchem Multi 1 & 2, Precinorm Protein &…JIX · Special | Roche Diagnostics | 11/26/2013SE |
| K130765 | Elitech Clinical Systems Elical 2; Elitech Clinical Systems Elitrol I, Elitech Clinical…JIX · Abbreviated | Elitechgroup | 04/04/2013SE |
| K123321 | Dimension Chemistry III CalibratoryJIX · Traditional | Siemens Healthcare Diagnostics | 02/15/2013SE |
| K123372 | Abbott Lipid Multi Constituent CalibratorJIX · Traditional | Abbott Laboratories | 01/14/2013SE |
| K122398 | Rapidpoint 500 System Measurement Cartridge with CalibratorsJIX · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/12/2012SE |
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| K012878 | Thermo Trace Ammonia Standards Set, Models TR-609JIS · Abbreviated | 10/16/2001SE |
| K012518 | Trace Scientific Alkaline Phosphatase, Two Part Liquid, Model TR-113CJE · Abbreviated | 10/09/2001SE |
| K012525 | Thermo Dma Fructosamine Assay, Model 7500-135/235LCP · Abbreviated | 10/04/2001SE |
Questions and answers
When was Thermo Dma Data-Cal Calibrator, Model 1905-050 cleared by the FDA?
Thermo Dma Data-Cal Calibrator, Model 1905-050 (K022108) received a 510(k) decision of Substantially Equivalent on July 25, 2002, 27 days after the submission was received.
What is the product code of K022108?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.