Uric Acid (Aox), Scal, Nortrol, Abtrol
FDA 510(k) K073612 · Thermofisher Scientific OY
510(k) numberK073612
Submission
- Device name
- Uric Acid (Aox), Scal, Nortrol, Abtrol
- Applicant
- Thermofisher Scientific OY
Vantaa, FI - Received
- December 21, 2007
- Decision date
- May 23, 2008
- 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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| 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 |
|---|---|---|
| K110035 | IndikoJJE · Traditional | 06/28/2011SE |
| K073295 | Urea/Bun, Scal, Nortrol, AbtrolCDQ · Traditional | 05/29/2008SE |
| K073355 | Calcium, Scal, Nortrol, AbtrolCJY · Traditional | 02/28/2008SE |
| K073191 | Alkaline Phosphatase (Ifcc) Plus, Ecal, Nortrol, AbtrolCJE · Traditional | 02/28/2008SE |
| K070824 | Creatinine (Enzymatic)JFY · Traditional | 12/03/2007SE |
| K071340 | Carbon Dioxide (CO2), Scal, Nortrol and AbtrolKHS · Traditional | 10/05/2007SE |
| K071580 | Ast/Got (Ifcc), Pyridoxal Phosphate, Ecal, Nortrol and AbtrolCIT · Traditional | 10/03/2007SE |
Questions and answers
When was Uric Acid (Aox), Scal, Nortrol, Abtrol cleared by the FDA?
Uric Acid (Aox), Scal, Nortrol, Abtrol (K073612) received a 510(k) decision of Substantially Equivalent on May 23, 2008, 154 days after the submission was received.
What is the product code of K073612?
The FDA product code is JIX – Calibrator, Multi-Analyte Mixture, a Class II (moderate risk) device regulated under 21 CFR 862.1150.