JIX · Class II · 21 CFR 862.1150

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
302 devices
25–48 of 302
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 Mar 05, 2008
ABX PENTRA URINE CAL
K071779
Horiba Abx
Chemistry · 247d
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
Cleared Jan 23, 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H
K063508
Dade Behring, Inc.
Chemistry · 64d
Cleared Oct 04, 2006
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE
K062035
Dade Behring, Inc.
Immunology · 77d
Cleared Sep 22, 2006
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
K062334
Dade Behring, Inc.
Chemistry · 43d
Cleared Sep 13, 2006
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
K062319
Roche Diagnostics Corp.
Chemistry · 35d
Cleared Sep 06, 2006
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
K062034
Dade Behring, Inc.
Chemistry · 49d
Cleared Aug 25, 2006
DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
K061923
Dade Behring, Inc.
Chemistry · 49d
Cleared Aug 25, 2006
DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
K062122
Dade Behring, Inc.
Chemistry · 31d
Cleared Aug 21, 2006
DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
K061838
Dade Behring, Inc.
Chemistry · 53d
Cleared Aug 11, 2006
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
K061750
Dade Behring, Inc.
Chemistry · 51d
Cleared Aug 07, 2006
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
K062055
Dade Behring, Inc.
Chemistry · 18d
Cleared Aug 02, 2006
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
K061703
Dade Behring, Inc.
Chemistry · 47d
Cleared Jul 20, 2006
RANDOX LIQUID PROTEIN CALIBRATOR
K061056
Randox Laboratories, Ltd.
Immunology · 94d
Cleared Jul 05, 2006
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
K061390
Dade Behring, Inc.
Chemistry · 48d
Cleared Jun 30, 2006
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
K061218
Dade Behring, Inc.
Chemistry · 60d
Cleared Apr 24, 2006
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III
K060940
Ortho-Clinical Diagnostics, Inc.
Immunology · 18d
Cleared Jan 13, 2006
RANDOX CALIBRATION SERUM
K053153
Randox Laboratories, Ltd.
Chemistry · 64d