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
49–72 of 302
Cleared Oct 25, 2005
SENTINEL CLIN CHEM CAL
K051452
Sentinel Ch. Srl
Chemistry · 145d
Cleared Aug 01, 2005
LIPOPROTEIN FOR MULTIPLE ANALYTES
K051619
Bayer Healthcare, LLC
Chemistry · 45d
Cleared Jul 25, 2005
SENTINEL PLASMAPROTEINS CAL 3X
K051457
Sentinel Ch. Srl
Chemistry · 53d
Cleared Jan 31, 2005
OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071
K043460
Olympus America, Inc.
Chemistry · 47d
Cleared Jan 31, 2005
PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC
K050026
Roche Diagnostics
Chemistry · 25d
Cleared Nov 23, 2004
HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278
K041926
Diagnostic Chemicals , Ltd.
Chemistry · 127d
Cleared Nov 16, 2004
MULTI-CHEM CALIBRATOR A
K042551
Wako Chemicals USA, Inc.
Chemistry · 57d
Cleared Nov 08, 2004
MULTI CHEM CAL B
K042549
Wako Chemicals USA, Inc.
Chemistry · 49d
Cleared Nov 08, 2004
MULTI-LIPID CALIBRATOR
K042550
Wako Chemicals USA, Inc.
Chemistry · 49d
Cleared Oct 04, 2004
MICROALBUMIN MULTI-CALIBRATOR SET
K042243
Diagnostic Chemicals , Ltd.
Chemistry · 46d
Cleared Sep 28, 2004
HEMOSIL CALIBRATION PLASMA
K041905
Instrumentation Laboratory CO
Hematology · 75d
Cleared Jul 27, 2004
N APOLIPOPROTEIN STANDARD SERUM
K041870
Dade Behring, Inc.
Chemistry · 18d
Cleared Apr 02, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF
K040264
Roche Diagnostics Corp.
Chemistry · 58d
Cleared Mar 24, 2004
CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC)
K040245
Roche Diagnostics Corp.
Chemistry · 50d
Cleared Mar 12, 2004
DIRECT LDL CHOLESTEROL LIQUID COLOR AND STANBIO DIRECT HDL/LDL CHOLESTEROL CALIBRATOR
K032936
Stanbio Laboratory
Chemistry · 172d
Cleared Feb 13, 2004
BAYER SPECIFIC PROTEIN REFERENCE SERUM
K033791
Bayer Healthcare, LLC
Chemistry · 71d
Cleared Feb 13, 2004
ELECSYS C-PEPTIDE CALSET
K033873
Roche Diagnostics Corp.
Toxicology · 60d
Cleared Jan 30, 2004
OLYMPUS URINE CALIBRATOR
K033910
Cliniqa Corporation
Chemistry · 44d
Cleared Dec 16, 2003
BAYER SPECIAL CHEMISTRY CALIBRATORS
K033380
Bayer Diagnostics Corp.
Chemistry · 55d
Cleared Nov 21, 2003
OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
K032665
Olympus America, Inc.
Chemistry · 85d
Cleared Nov 20, 2003
MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS)
K033501
Roche Diagnostics Corp.
Chemistry · 15d
Cleared Nov 07, 2003
CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE
K033061
Diamond Diagnostics, Inc.
Chemistry · 39d
Cleared Aug 18, 2003
MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2
K032287
Beckman Coulter, Inc.
Chemistry · 25d
Cleared Aug 08, 2003
RANDOX LIQUID PROTEIN CALIBRATOR
K031608
Randox Laboratories, Ltd.
Chemistry · 78d