FDA Product Code JIX: Calibrator, Multi-analyte Mixture
Leading manufacturers include Alko Diagnostic Corp., Dade Behring, Inc. and Bhp Diagnostix, Inc..
302
Total
302
Cleared
66d
Avg days
1976
Since
FDA 510(k) Cleared Calibrator, Multi-analyte Mixture Devices (Product Code JIX)
302 devices
Cleared
May 20, 2016
VITROS Chemistry Products Calibrator Kit 3
Ortho-Clinical Diagnostics, Inc.
Chemistry
28d
Cleared
Dec 18, 2015
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
Siemens Healthcare Diagnostics, Inc.
Chemistry
28d
Cleared
Jul 08, 2015
ELITech Clinical Systems ELICAL 2, ELITech Clinical Systems ELITROL I, ELITech Clinical Systems ELITROL II
Elitechgroup
Chemistry
29d
Cleared
Jun 15, 2015
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
Siemens Healthcare Diagnostics
Chemistry
441d
Cleared
Jul 11, 2014
SYSTEM CALIBRATER
Beckman Coulter Ireland, Inc.
Chemistry
45d
Cleared
Nov 26, 2013
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
Roche Diagnostics
Chemistry
25d
Cleared
Apr 04, 2013
ELITECH CLINICAL SYSTEMS ELICAL 2
Elitechgroup
Chemistry
15d
Cleared
Feb 15, 2013
DIMENSION CHEMISTRY III CALIBRATORY
Siemens Healthcare Diagnostics
Chemistry
112d
Cleared
Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
Abbott Laboratories
Chemistry
74d
Cleared
Oct 12, 2012
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
Siemens Healthcare Diagnostics, Inc.
Chemistry
66d
Cleared
Mar 28, 2012
MULTI-CHEMISTRY STANDARD KIT, URIC ACID STANDARD KIT, URINE CHEMISTRY STARDAND KIT, URINE URIC ACID STANDARD KIT, CHOLES
Verichem Laboratories, Inc.
Chemistry
182d
Cleared
Aug 30, 2011
ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05
Elitechgroup
Chemistry
46d
Cleared
Jun 09, 2011
ATAC SERUM CALIBRATOR (DIRECT BILIRUBIN AND IRON)
Vital Diagnostics (Manufacturing) Ptyltd
Chemistry
118d
Cleared
May 25, 2011
SYNCHRON MULTI CALIBRATOR
Beckman Coulter, Inc.
Chemistry
117d
Cleared
Feb 18, 2011
ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
Siemens Healthcare Diagnostics, Inc.
Immunology
60d
Cleared
Feb 11, 2011
ELECSYS ANTI-TPO CALSET
Roche Diagnostics
Immunology
107d
Cleared
Feb 04, 2011
MULTICONSTITUENT CALIBRATOR
Abbott Laboratories
Chemistry
77d
Cleared
Jan 25, 2011
DIMENSION VISA ENZ 2 CAL
Siemens Healthcare Diagnostics, Inc.
Chemistry
47d
Cleared
Sep 08, 2010
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
Roche Diagnostics
Chemistry
105d
Cleared
Jul 09, 2010
LOCI 8 CALIBRATOR, MODEL KC 646
Siemens Healthcare Diagnostics
Chemistry
44d
Cleared
May 05, 2010
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
Siemens Healthcare Diagnostics
Chemistry
47d
Cleared
Mar 22, 2010
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
Siemens Healthcare Diagnostics
Chemistry
108d
Cleared
Mar 05, 2010
EXL ANEM CAL, MODEL RC640
Siemens Healthcare Diagnostics
Chemistry
100d
Cleared
Nov 13, 2009
STA - FREE PS CALIBRATOR
Diagnostica Stago, Inc.
Hematology
122d