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
217–240 of 302
Cleared Feb 27, 1985
ROCHE STANDARDS FOR CHLORIDE & CO2
K850396
Roche Diagnostic Systems, Inc.
Chemistry · 26d
Cleared Dec 11, 1984
REFERRIL CALIBRATORS
K844585
Instrumentation Laboratory CO
Chemistry · 18d
Cleared Nov 27, 1984
SERACON TM SR IV
K844026
Bhp Diagnostix, Inc.
Chemistry · 43d
Cleared Nov 27, 1984
SERACON TM SR III
K844027
Bhp Diagnostix, Inc.
Chemistry · 43d
Cleared Oct 17, 1984
DOUMENT TM LINEARITY TEST STANDARDS
K843947
Casco Standards
Chemistry · 8d
Cleared Jun 22, 1984
CHANGES IN THE CHEMICAL COMP. OF 5
K841464
Nova Biomedical Corp.
Chemistry · 102d
Cleared May 11, 1984
SODIUM & POTASSIUM STANDARD SOLUT
K841419
Reagent Laboratory, Inc.
Chemistry · 36d
Cleared May 11, 1984
SODIUM & POTASSIUM STANDARD SOL 80
K841420
Reagent Laboratory, Inc.
Chemistry · 36d
Cleared Mar 23, 1984
TRIGLYCERIDE/CHOLESTEROL AQUEOUS
K840219
Preventive Diagnostics Corp.
Chemistry · 64d
Cleared Mar 23, 1984
HDL CHOLESTEROL CONTROLS-LEVELS
K840278
Preventive Diagnostics Corp.
Chemistry · 60d
Cleared Nov 14, 1983
PARAMAX BILIRUBIN CALIBRATORS
K833005
American Dade
Chemistry · 94d
Cleared Oct 04, 1983
LYPHOCHEK SERUM REF. STANDARD-BOVINE
K832695
Bio-Rad
Chemistry · 55d
Cleared Aug 11, 1983
SERALYZER MULTICOMPONENT CALIBRATORS
K832046
Miles Laboratories, Inc.
Chemistry · 48d
Cleared May 09, 1983
COBAS STANDARDS FOR GLUCOSE & BUN
K831030
Roche Diagnostic Systems, Inc.
Chemistry · 40d
Cleared Mar 10, 1983
SALT BRIDGE SOLUTION & URINE DILUENT
K830341
Shaban Mfg. Co.
Chemistry · 36d
Cleared Nov 05, 1982
GLUCOSE/UREA NITROGEN STANDARD
K822937
Emd Chemicals, Inc.
Chemistry · 32d
Cleared Aug 24, 1982
CO2/CI STANDARDS
K822289
Gilford Diagnostics
Chemistry · 22d
Cleared Jul 13, 1982
REF. ELECTRODE SOL'N.
K821885
Avl Scientific Corp.
Chemistry · 18d
Cleared Jul 02, 1982
NOVA V FLUIDS PACK & EXTERNAL STANDARDS
K821794
Shaban Mfg. Co.
Chemistry · 14d
Cleared Jun 14, 1982
NOVA IV FLUIDS PACK & EXTERNAL STANDARDS
K821623
Shaban Mfg. Co.
Chemistry · 12d
Cleared May 03, 1982
NOVA II FLUIDS PACK
K821030
Shaban Mfg. Co.
Chemistry · 20d
Cleared Apr 26, 1982
NOVA III FLUIDS PACK
K820947
Shaban Mfg. Co.
Chemistry · 20d
Cleared Apr 01, 1982
EXTERNAL STANDARDS-SODIUMNPOTASSIUM
K820700
Shaban Mfg. Co.
Chemistry · 17d
Cleared Apr 01, 1982
NOVA I FLUIDS PACK
K820701
Shaban Mfg. Co.
Chemistry · 17d