JIX · Calibrator, Multi-Analyte Mixture
Clinical Chemistry · 21 CFR 862.1150 · Class 2
Overview
| Product Code | JIX |
|---|---|
| Device Name | Calibrator, Multi-Analyte Mixture |
| Regulation | 21 CFR 862.1150 |
| Device Class | Class 2 |
| Review Panel | Clinical Chemistry |
Identification
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
Recent Cleared Devices (20 of 302)
Showing 20 most recent of 302 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K161140 | VITROS Chemistry Products Calibrator Kit 3 | Ortho-Clinical Diagnostics, Inc. | May 20, 2016 | SESE |
| K153365 | ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator | Siemens Healthcare Diagnostics, Inc. | Dec 18, 2015 | SESE |
| K151552 | ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II | Elitechgroup | Jul 8, 2015 | SESE |
| K140790 | Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) | Siemens Healthcare Diagnostics | Jun 15, 2015 | SESE |
| K141388 | SYSTEM CALIBRATER | Beckman Coulter Ireland, Inc. | Jul 11, 2014 | SESE |
| K133330 | C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN | Roche Diagnostics | Nov 26, 2013 | SESE |
| K130765 | ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II | Elitechgroup | Apr 4, 2013 | SESE |
| K123321 | DIMENSION CHEMISTRY III CALIBRATORY | Siemens Healthcare Diagnostics | Feb 15, 2013 | SESE |
| K123372 | ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR | Abbott Laboratories | Jan 14, 2013 | SESE |
| K122398 | RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | Oct 12, 2012 | SESE |
| K112834 | MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES | Verichem Laboratories, Inc. | Mar 28, 2012 | SESE |
| K112029 | ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 | Elitechgroup | Aug 30, 2011 | SESE |
| K110394 | ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON) | Vital Diagnostics (Manufacturing) Ptyltd | Jun 9, 2011 | SESE |
| K110251 | SYNCHRON MULTI CALIBRATOR | Beckman Coulter, Inc. | May 25, 2011 | SESE |
| K103701 | ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS | Siemens Healthcare Diagnostics, Inc. | Feb 18, 2011 | SESE |
| K103171 | ELECSYS ANTI-TPO CALSET | Roche Diagnostics | Feb 11, 2011 | SESE |
| K103403 | MULTICONSTITUENT CALIBRATOR | Abbott Laboratories | Feb 4, 2011 | SESE |
| K103612 | DIMENSION VISA ENZ 2 CAL | Siemens Healthcare Diagnostics, Inc. | Jan 25, 2011 | SESE |
| K101456 | ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM | Roche Diagnostics | Sep 8, 2010 | SESE |
| K101460 | LOCI 8 CALIBRATOR, MODEL KC 646 | Siemens Healthcare Diagnostics | Jul 9, 2010 | SESE |
Top Applicants
- Alko Diagnostic Corp. — 21 clearances
- Dade Behring, Inc. — 18 clearances
- Bhp Diagnostix, Inc. — 11 clearances
- Roche Diagnostics Corp. — 10 clearances
- Roche Diagnostic Systems, Inc. — 9 clearances
