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..

268
Total
268
Cleared
109d
Avg days
1977
Since
268 devices
49–72 of 268
Cleared Mar 21, 1995
LATEX (K82)
K931746
Diagnostic Products Corp.
Immunology · 712d
Cleared Mar 13, 1995
HY-TEC AUTOMATED EIA SYSTEM
K941278
Hycor Biomedical, Inc.
Immunology · 361d
Cleared Mar 06, 1995
HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT
K943768
Diagnostic Products Corp.
Immunology · 216d
Cleared Jan 20, 1995
SPECIFIC IGE EIA-ULTRA ASSAY
K941057
Hycor Biomedical, Inc.
Immunology · 318d
Cleared Dec 19, 1994
IMMULITE ALATOP ALLERGY SCREEN
K941564
Diagnostic Products Corp.
Immunology · 262d
Cleared Mar 22, 1994
ALATOP(R) MICROPLATE ALLERGY SCREEN
K935488
Diagnostic Products Corp.
Immunology · 127d
Cleared Mar 11, 1994
ACCESS SPECIFIC IGE ASSAY
K935876
Bio-Rad Laboratories, Inc.
Immunology · 92d
Cleared Feb 23, 1993
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
K923420
Ciba Corning Diagnostics Corp.
Immunology · 225d
Cleared Jan 14, 1993
SPECIFIC IGE EIA-TURBO ASSAY
K925425
Hycor Biomedical, Inc.
Immunology · 79d
Cleared Dec 01, 1992
VENTREX ALLERGEN DISC
K924044
Hycor Biomedical, Inc.
Immunology · 112d
Cleared Nov 30, 1992
VENTREX ALLERGEN DISC
K924209
Hycor Biomedical, Inc.
Immunology · 102d
Cleared Sep 28, 1992
BASELINE CALIBRATION VERIFICATION CONTROLS
K923284
Hycor Biomedical, Inc.
Immunology · 84d
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 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 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 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