Rapidpoint 500 System Measurement Cartridge with Calibrators
FDA 510(k) K122398 · Siemens Healthcare Diagnostics, Inc.
510(k) numberK122398
Submission
- Device name
- Rapidpoint 500 System Measurement Cartridge with Calibrators
- Applicant
- Siemens Healthcare Diagnostics, Inc.
Norowood, MA, US - Received
- August 7, 2012
- Decision date
- October 12, 2012
- 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 |
| K112834 | Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit…JIX · Abbreviated | Verichem Laboratories, Inc. | 03/28/2012SE |
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Questions and answers
When was Rapidpoint 500 System Measurement Cartridge with Calibrators cleared by the FDA?
Rapidpoint 500 System Measurement Cartridge with Calibrators (K122398) received a 510(k) decision of Substantially Equivalent on October 12, 2012, 66 days after the submission was received.
What is the product code of K122398?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.