Multi-Analyte Chemistry Calibrator
FDA 510(k) K070207 · Pointe Scientific, Inc.,
510(k) numberK070207
Submission
- Device name
- Multi-Analyte Chemistry Calibrator
- Applicant
- Pointe Scientific, Inc.,
Lincoln Park, MI, US - Received
- January 22, 2007
- Decision date
- April 13, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement 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.
| 510(k) | Device | Decision |
|---|---|---|
| K070757 | Microprotein Reagent SetJGP · Traditional | 12/04/2007SE |
| K062118 | Pointe 360CFR · Traditional | 07/13/2007SE |
| K070251 | Carbon Dioxide Liquid Stable ReagentKHS · Traditional | 04/30/2007SE |
| K070504 | Ammonia/Alcohol Control SetJJY · Abbreviated | 04/11/2007SE |
| K061377 | Apolipoprotein A1 and Apolipoprotein B Reagents and CalibratorsMSJ · Traditional | 03/28/2007SE |
| K051646 | Ise Diluent, 1N KCL, Internal Reference and Ise Standards Low and HighJGS · Traditional | 10/07/2005SE |
| K040391 | Total Bilirubin Reagent SetCIG · Traditional | 06/02/2004SE |
| K031539 | Hemoglobin A1C Reagent SetLCP · Traditional | 08/06/2003SE |
| K023860 | Microalbumin Reagent Set and CalibratorsDDZ · Traditional | 04/28/2003SE |
| K024006 | G6PDH, GLUCOSE-6-PHOSHATE DehydrogenaseJBF · Traditional | 03/31/2003SE |
Questions and answers
When was Multi-Analyte Chemistry Calibrator cleared by the FDA?
Multi-Analyte Chemistry Calibrator (K070207) received a 510(k) decision of Substantially Equivalent on April 13, 2007, 81 days after the submission was received.
What is the product code of K070207?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.