DHB · Class II · 21 CFR 866.5750

FDA Product Code DHB: System, Test, Radioallergosorbent (rast) Immunological

Leading manufacturers include Pharmacia, Inc., Diagnostic Products Corp. and Incstar Corp..

269
Total
269
Cleared
110d
Avg days
1977
Since
269 devices
97–120 of 269
Cleared Sep 28, 1992
BASELINE CALIBRATION VERIFICATION CONTROLS
K923284
Hycor Biomedical, Inc.
Immunology · 84d
Cleared Sep 14, 1992
866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS
K914685
In Vitro Technologies, Inc.
Immunology · 332d
Cleared Aug 20, 1992
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K914959
Ciba Corning Diagnostics Corp.
Immunology · 289d
Cleared Aug 03, 1992
WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC
K921574
Hycor Biomedical, Inc.
Immunology · 123d
Cleared Jul 27, 1992
VENTREX ALLERGEN DISC
K922538
Hycor Biomedical, Inc.
Immunology · 59d
Cleared Mar 13, 1992
SPECIFIC IGE EIA-TURBO ASSAY
K914554
Ventrex Laboratories, Inc.
Immunology · 154d
Cleared Feb 21, 1992
VENTREX ALLERGEN DISC
K913833
Ventrex Laboratories, Inc.
Immunology · 179d
Cleared Dec 09, 1991
CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE
K914850
Mast Immunosystems
Immunology · 42d
Cleared Nov 29, 1991
ABBOTT MATRIX AERO PLUS SYSTEM
K913150
Abbott Laboratories
Immunology · 136d
Cleared Nov 22, 1991
ALLERGY INFORMATION MANAGER
K912294
Diagnostic Products Corp.
Immunology · 186d
Cleared Nov 22, 1991
3M IGE SINGLE POINT FAST TEST
K913212
Whittaker Bioproducts, Inc.
Immunology · 126d
Cleared Oct 02, 1991
FASTTECH SYSTEM II
K913892
3M Diagnostic Systems, Inc.
Immunology · 33d
Cleared Aug 12, 1991
ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA
K911903
Pharmacia, Inc.
Immunology · 105d
Cleared Jul 31, 1991
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K912582
Ciba Corning Diagnostics Corp.
Immunology · 49d
Cleared Apr 17, 1991
ALLERGEN MODULES FOR ALASTAT TM
K894227
Diagnostic Products Corp.
Immunology · 667d
Cleared Apr 05, 1991
MAST CLA ALLERGY SYSTEM
K910292
Mast Immunosystems
Immunology · 72d
Cleared Mar 22, 1991
CIBA CORNING MODEL 980 MAGIC LITE ALLERGY MANAGER
K905054
Ciba Corning Diagnostics Corp.
Immunology · 134d
Cleared Mar 05, 1991
CAP SYSTEM RAST ASM/RIA AND ASM/FEIA
K910517
Pharmacia, Inc.
Immunology · 28d
Cleared Feb 07, 1991
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
K905636
Ventrex Laboratories, Inc.
Immunology · 52d
Cleared Jan 30, 1991
SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE
K910075
Diagnostic Products Corp.
Immunology · 22d
Cleared Jan 14, 1991
QUIDEL TOTAL IGE POSITIVE CONTROL SERUM
K905162
Quidel Corp.
Immunology · 59d
Cleared Dec 13, 1990
POSITIVE CONTROL PAD ALLERGEN/FOOD ALLERGEN SCREEN
K905176
Quidel Corp.
Immunology · 24d
Cleared Dec 07, 1990
TURBO-RAST SPECIFIC IGE ASSAY
K904330
Ventrex Laboratories, Inc.
Immunology · 78d
Cleared Nov 29, 1990
IVT RAST TRACER
K904661
In Vitro Technologies, Inc.
Immunology · 48d