Bayer Advia 1650 Special Chemistry Calibrator
FDA 510(k) K030804 · Bayer Healthcare, LLC
510(k) numberK030804
Submission
- Device name
- Bayer Advia 1650 Special Chemistry Calibrator
- Applicant
- Bayer Healthcare, LLC
Tarrytown, NY, US - Received
- March 13, 2003
- Decision date
- April 10, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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
Other 510(k)s with product code JIX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161140 | VITROS Chemistry Products Calibrator Kit 3JIX · Abbreviated | Ortho-Clinical Diagnostics, Inc. | 05/20/2016SE |
| K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 CalibratorJIX · Traditional | Siemens Healthcare Diagnostics, Inc. | 12/18/2015SE |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical…JIX · Abbreviated | Elitechgroup | 07/08/2015SE |
| 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 |
More from Siemens Healthcare Diagnostics, Inc.
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| K150942 | Contour Next USB Blood Glucose Monitoring SystemNBW · Special | 11/25/2015SE |
| K151742 | Contour Next Control SolutionJJX · Traditional | 09/23/2015SE |
| K130265 | Contour Next Ez Blood Glucose MeterNBW · Traditional | 06/23/2014SE |
| K122370 | Contour Next Link Wireless Blood Glucose MonitorNBW · Traditional | 09/26/2013SE |
| K121190 | Contour Next Blood Glucose MeterLFR · Special | 07/26/2012SE |
| K121087 | Contour Next Usb Blood Glucose Monitoring SystemNBW · Special | 06/28/2012SE |
| K110894 | Contour Next Link Wireless Blood Glucose MeterLFR · Traditional | 03/28/2012SE |
| K110587 | Contour Link Blood Glucose Meter, Contour Blood Glucose Test Strips, Contour Control…LFR · Traditional | 03/28/2012SE |
Questions and answers
When was Bayer Advia 1650 Special Chemistry Calibrator cleared by the FDA?
Bayer Advia 1650 Special Chemistry Calibrator (K030804) received a 510(k) decision of Substantially Equivalent on April 10, 2003, 28 days after the submission was received.
What is the product code of K030804?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.