Sta - Free PS Calibrator
FDA 510(k) K092113 · Diagnostica Stago, Inc.
510(k) numberK092113
Submission
- Device name
- Sta - Free PS Calibrator
- Applicant
- Diagnostica Stago, Inc.
Parisppany, NJ, US - Received
- July 14, 2009
- Decision date
- November 13, 2009
- 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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| 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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| K093167 | Sta Compact Automated Multi-Parametric AnalyzerJPA · Special | 12/22/2009SE |
| K092170 | Sta Liatest Free PSGGP · Special | 12/22/2009SE |
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Questions and answers
When was Sta - Free PS Calibrator cleared by the FDA?
Sta - Free PS Calibrator (K092113) received a 510(k) decision of Substantially Equivalent on November 13, 2009, 122 days after the submission was received.
What is the product code of K092113?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.