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
73–96 of 302
Cleared Aug 06, 2003
TOX AMMONIA CALIBRATOR
K031683
Bayer Healthcare, LLC
Chemistry · 68d
Cleared Jul 16, 2003
AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
K031880
Roche Diagnostics Corp.
Chemistry · 28d
Cleared Jun 25, 2003
LIPOPROTEIN CALIBRATOR
K031682
Bayer Healthcare, LLC
Chemistry · 26d
Cleared Apr 10, 2003
BAYER ADVIA 1650 SPECIAL CHEMISTRY CALIBRATOR
K030804
Bayer Healthcare, LLC
Chemistry · 28d
Cleared Mar 18, 2003
WIENER LAB. CALIBRATOR A PLUS, MODEL 2X3 ML CAT. NR. 1918006
K024305
Wiener Laboratories Saic
Chemistry · 84d
Cleared Jan 31, 2003
SETPOINT CHEMISTRY CALIBRATOR
K030169
Bayer Healthcare, LLC
Chemistry · 14d
Cleared Jan 21, 2003
LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS
K030074
Cliniqa Corporation
Immunology · 13d
Cleared Dec 10, 2002
VITROS CHEMISTRY PRODUCTS MG SLIDE, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
K023876
Ortho-Clinical Diagnostics, Inc.
Toxicology · 19d
Cleared Nov 15, 2002
PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
K023268
Phoenix Diagnostics, Inc.
Chemistry · 46d
Cleared Oct 24, 2002
RANDOX APOLIPOPROTEIN CALIBRATOR
K023158
Randox Laboratories, Ltd.
Chemistry · 31d
Cleared Sep 03, 2002
RAICHEM LIPID CALIBRATOR
K022767
Hemagen Diagnostics, Inc.
Chemistry · 13d
Cleared Feb 15, 2002
PACIFIC HEMOSTASIS REFERENCE EMULSION
K013397
Fisher Diagnostics
Hematology · 123d
Cleared Feb 01, 2002
PHOENIX ELETROLYTE CALIBRATION SET FOR THE ROCHE COBAS ISE MODULE
K020129
Phoenix Diagnostics, Inc.
Chemistry · 18d
Cleared Dec 18, 2001
DC-UIBC-CO2-CAL, MODEL SE-153
K013178
Diagnostic Chemicals , Ltd.
Chemistry · 85d
Cleared Nov 07, 2001
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER
K012987
Phoenix Diagnostics, Inc.
Chemistry · 62d
Cleared Oct 09, 2001
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE DADE/BEHRING/BEHRING DIMENSION CHEMISTRY SYSTEM
K012509
Phoenix Diagnostics, Inc.
Chemistry · 64d
Cleared Sep 28, 2001
MODIFICATION TO N PROTEIN STANDARD SL
K012470
Dade Behring, Inc.
Chemistry · 57d
Cleared Sep 24, 2001
RAICHEM MULTI-ANALYTE CALIBRATOR
K012250
Hemagen Diagnostics, Inc.
Chemistry · 69d
Cleared Jun 25, 2001
CALIBRATOR FOR AUTOMATED SYSTEMS
K011226
Roche Diagnostics Corp.
Chemistry · 66d
Cleared Jun 14, 2001
DIMENSION DRUG CALIBRATOR, MODEL DC22B
K011035
Dade Behring, Inc.
Chemistry · 70d
Cleared Mar 30, 2001
SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936
K010652
Sigma Diagnostics, Inc.
Chemistry · 25d
Cleared Oct 05, 2000
N PROTEIN STANDARD SL
K002804
Dade Behring, Inc.
Chemistry · 27d
Cleared Jun 19, 2000
CALIBRATION SOLUTION 1, MODEL A943-837
K001484
Alko Diagnostic Corp.
Chemistry · 39d
Cleared Mar 21, 2000
ELECSYS CORTISOL CALCHECK
K000576
Roche Diagnostics Corp.
Chemistry · 28d