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
Cleared
Jan 14, 2013
ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR
Abbott Laboratories
Chemistry
74d
Cleared
May 25, 2011
SYNCHRON MULTI CALIBRATOR
Beckman Coulter, Inc.
Chemistry
117d
Cleared
Feb 04, 2011
MULTICONSTITUENT CALIBRATOR
Abbott Laboratories
Chemistry
77d
Cleared
May 12, 2008
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160
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
Dade Behring, Inc.
Chemistry
48d
Cleared
Jan 23, 2007
DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H
Dade Behring, Inc.
Chemistry
64d
Cleared
Oct 04, 2006
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE
Dade Behring, Inc.
Immunology
77d
Cleared
Sep 22, 2006
DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130
Dade Behring, Inc.
Chemistry
43d
Cleared
Sep 13, 2006
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360
Roche Diagnostics Corp.
Chemistry
35d
Cleared
Sep 06, 2006
DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410)
Dade Behring, Inc.
Chemistry
49d
Cleared
Aug 25, 2006
DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310)
Dade Behring, Inc.
Chemistry
49d
Cleared
Aug 25, 2006
DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130)
Dade Behring, Inc.
Chemistry
31d
Cleared
Aug 21, 2006
DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110
Dade Behring, Inc.
Chemistry
53d
Cleared
Aug 11, 2006
DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220
Dade Behring, Inc.
Chemistry
51d
Cleared
Aug 07, 2006
DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH
Dade Behring, Inc.
Chemistry
18d
Cleared
Aug 02, 2006
DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120)
Dade Behring, Inc.
Chemistry
47d
Cleared
Jul 05, 2006
DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320
Dade Behring, Inc.
Chemistry
48d
Cleared
Jun 30, 2006
DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140
Dade Behring, Inc.
Chemistry
60d
Cleared
Sep 28, 2004
HEMOSIL CALIBRATION PLASMA
Instrumentation Laboratory CO
Hematology
75d
Cleared
Jul 27, 2004
N APOLIPOPROTEIN STANDARD SERUM
Dade Behring, Inc.
Chemistry
18d
Cleared
Apr 02, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
Roche Diagnostics Corp.
Chemistry
58d
Cleared
Mar 24, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
Roche Diagnostics Corp.
Chemistry
50d
Cleared
Feb 13, 2004
ELECSYS C-PEPTIDE CALSET
Roche Diagnostics Corp.
Toxicology
60d
Cleared
Nov 20, 2003
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
Roche Diagnostics Corp.
Chemistry
15d