JIX · Class II · 21 CFR 862.1150

FDA Product Code JIX: Calibrator, Multi-analyte Mixture

Leading manufacturers include Dade Behring, Inc., Roche Diagnostics Corp. and Roche Diagnostic Systems, Inc..

302
Total
302
Cleared
66d
Avg days
1976
Since

FDA 510(k) Cleared Calibrator, Multi-analyte Mixture Devices (Product Code JIX)

302 devices
1–24 of 302
Cleared May 20, 2016
VITROS Chemistry Products Calibrator Kit 3
K161140
Ortho-Clinical Diagnostics, Inc.
Chemistry · 28d
Cleared Dec 18, 2015
ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator
K153365
Siemens Healthcare Diagnostics, Inc.
Chemistry · 28d
Cleared Jun 15, 2015
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG)
K140790
Siemens Healthcare Diagnostics
Chemistry · 441d
Cleared Nov 26, 2013
C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN
K133330
Roche Diagnostics
Chemistry · 25d
Cleared Feb 15, 2013
DIMENSION CHEMISTRY III CALIBRATORY
K123321
Siemens Healthcare Diagnostics
Chemistry · 112d
Cleared Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
K123372
Abbott Laboratories
Chemistry · 74d
Cleared Oct 12, 2012
RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS
K122398
Siemens Healthcare Diagnostics, Inc.
Chemistry · 66d
Cleared May 25, 2011
SYNCHRON MULTI CALIBRATOR
K110251
Beckman Coulter, Inc.
Chemistry · 117d
Cleared Feb 18, 2011
ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS
K103701
Siemens Healthcare Diagnostics, Inc.
Immunology · 60d
Cleared Feb 11, 2011
ELECSYS ANTI-TPO CALSET
K103171
Roche Diagnostics
Immunology · 107d
Cleared Feb 04, 2011
MULTICONSTITUENT CALIBRATOR
K103403
Abbott Laboratories
Chemistry · 77d
Cleared Jan 25, 2011
DIMENSION VISA ENZ 2 CAL
K103612
Siemens Healthcare Diagnostics, Inc.
Chemistry · 47d
Cleared Sep 08, 2010
ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM
K101456
Roche Diagnostics
Chemistry · 105d
Cleared Jul 09, 2010
LOCI 8 CALIBRATOR, MODEL KC 646
K101460
Siemens Healthcare Diagnostics
Chemistry · 44d
Cleared May 05, 2010
DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A
K100778
Siemens Healthcare Diagnostics
Chemistry · 47d
Cleared Mar 22, 2010
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770
K093732
Siemens Healthcare Diagnostics
Chemistry · 108d
Cleared Mar 05, 2010
EXL ANEM CAL, MODEL RC640
K093645
Siemens Healthcare Diagnostics
Chemistry · 100d
Cleared Mar 13, 2009
EASYQC - CHEMISTRY WITH ELECTROLYTES
K080404
Medica Corp.
Chemistry · 393d
Cleared Feb 20, 2009
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360
K083579
Siemens Healthcare Diagnostics
Chemistry · 78d
Cleared May 23, 2008
LOCI THYROID CALIBRATOR WITH MODEL RC610
K081103
Siemens Healthcare Diagnostics, Inc.
Chemistry · 35d
Cleared May 12, 2008
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
K080607
Roche Diagnostics Corp.
Chemistry · 69d
Cleared Oct 17, 2007
DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H
K072435
Dade Behring, Inc.
Chemistry · 48d
Cleared Jul 20, 2007
VITROS CHEMISTRY PRODUCTS CI-SLIDES, CALIBRATOR KIT 2, MODEL(S) 844-5207, 166-2659
K071801
Ortho-Clinical Diagnostics, Inc.
Chemistry · 18d
Cleared Apr 13, 2007
MULTI-ANALYTE CHEMISTRY CALIBRATOR
K070207
Pointe Scientific, Inc.,
Chemistry · 81d

About Product Code JIX - Regulatory Context