Olympus Urine Calibrator
FDA 510(k) K033910 · Cliniqa Corporation
510(k) numberK033910
Submission
- Device name
- Olympus Urine Calibrator
- Applicant
- Cliniqa Corporation
Fallbrook, CA, US - Received
- December 17, 2003
- Decision date
- January 30, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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| 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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|---|---|---|
| K120900 | I-Stat PT Control Leviel 1 I-Stat PT Control Level 2GGN · Traditional | 05/31/2013SE |
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| K083554 | Cliniqa Liquidqc Immunoassay Control Level 1, 2 & 3JJY · Traditional | 04/21/2009SE |
| K081908 | Cliniqa Liquid QC Urinalysis Controls, Levels 1 and 2JJW · Traditional | 01/16/2009SE |
| K082107 | Cliniqa Liquid QC Urine Chemistry Controls, Levels 1 and 2JJY · Traditional | 09/17/2008SE |
| K080973 | Cliniqa Liquid QC Complete Cardiac Marker Control, Levels 1,2, and 3; Cardiac Marker…JJY · Traditional | 06/02/2008SE |
| K070741 | Cliniqa Liquid QC Unassayed and Assayed General Chemistry Control Levels 1, 2, & 3JJY · Traditional | 05/04/2007SE |
| K062916 | Cliniqa Liquid QC Cardiac Marker Control SP, Levels 1,2, &3JJY · Traditional | 10/23/2006SE |
| K061182 | Cliniqa Liquid QC Lipid Control Levels 1 & 2;LINICAL Lipid Calibration Verifiers Levels…JJY · Traditional | 05/25/2006SE |
| K060322 | Cliniqa Dry QC Chemistry Control, Levels 1 and 2, Assayed, Cliniqa Dry QC Chemistry…JIT · Traditional | 03/21/2006SE |
Questions and answers
When was Olympus Urine Calibrator cleared by the FDA?
Olympus Urine Calibrator (K033910) received a 510(k) decision of Substantially Equivalent on January 30, 2004, 44 days after the submission was received.
What is the product code of K033910?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.