JIX — Calibrator, Multi-Analyte Mixture Class II
FDA product code JIX covers "Calibrator, Multi-Analyte Mixture", a Class II medical device regulated under 21 CFR 862.1150. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JIX
- Device Class
- Class II
- Regulation Number
- 862.1150
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K161140 | ortho-clinical diagnostics | VITROS Chemistry Products Calibrator Kit 3 | May 20, 2016 |
| K153365 | siemens healthcare diagnostics | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | December 18, 2015 |
| K151552 | elitechgroup | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech C | July 8, 2015 |
| K140790 | siemens healthcare diagnostics | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium F | June 15, 2015 |
| K141388 | beckman coulter ireland | SYSTEM CALIBRATER | July 11, 2014 |
| K133330 | roche diagnostics | C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PR | November 26, 2013 |
| K130765 | elitechgroup | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH C | April 4, 2013 |
| K123321 | siemens healthcare diagnostics | DIMENSION CHEMISTRY III CALIBRATORY | February 15, 2013 |
| K123372 | abbott laboratories | ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR | January 14, 2013 |
| K122398 | siemens healthcare diagnostics | RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS | October 12, 2012 |
| K112834 | verichem laboratories | MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND K | March 28, 2012 |
| K112029 | elitechgroup | ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH C | August 30, 2011 |
| K110394 | vital diagnostics (manufacturing) ptyltd | ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) | June 9, 2011 |
| K110251 | beckman coulter | SYNCHRON MULTI CALIBRATOR | May 25, 2011 |
| K103701 | siemens healthcare diagnostics | ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS | February 18, 2011 |
| K103171 | roche diagnostics | ELECSYS ANTI-TPO CALSET | February 11, 2011 |
| K103403 | abbott laboratories | MULTICONSTITUENT CALIBRATOR | February 4, 2011 |
| K103612 | siemens healthcare diagnostics | DIMENSION VISA ENZ 2 CAL | January 25, 2011 |
| K101456 | roche diagnostics | ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR | September 8, 2010 |
| K101460 | siemens healthcare diagnostics | LOCI 8 CALIBRATOR, MODEL KC 646 | July 9, 2010 |