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
73–96 of 269
Cleared Sep 12, 1996
UNICAP 100
K962274
Pharmacia, Inc.
Immunology · 91d
Cleared Jan 30, 1996
PHARMACIA CAP SYSTEM PHADIATOP FEIA
K941993
Pharmacia, Inc.
Immunology · 645d
Cleared Dec 18, 1995
SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM
K954566
Diagnostic Products Corp.
Immunology · 77d
Cleared Nov 14, 1995
ACCESS ALLERGEN DOG EPITHELIM
K953780
Bio-Rad Laboratories, Inc.
Immunology · 92d
Cleared Oct 02, 1995
QUICKVUE ONE-STEP ALLERGEN SCREEN
K950728
Quidel Corp.
Immunology · 228d
Cleared Aug 15, 1995
ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN
K953014
Diagnostic Products Corp.
Immunology · 47d
Cleared Jun 30, 1995
SPECIFIC IGE ULTRA-EIA
K945884
Hycor Biomedical, Inc.
Immunology · 211d
Cleared Jun 07, 1995
HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY
K945748
Hycor Biomedical, Inc.
Immunology · 196d
Cleared May 23, 1995
ACCESS ALLERGENS - FEMATOPHAGOIDES FARINAE, CAT DANDER, TIMOTHY GRASS, AND ALTERNARIA ALTERNATA WHICH ARE SPECIFIC IGEZR
K950629
Bio-Rad Laboratories, Inc.
Immunology · 99d
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 Mar 07, 1994
MAST CLA ALLERGY SYSTEM
K926420
Mast Immunosystems
Immunology · 439d
Cleared Mar 07, 1994
MAST CLA ALLERGY SYSTEM
K934524
Mast Immunosystems
Immunology · 168d
Cleared May 14, 1993
VENTREX ALLERGEN DISC
K925044
Ventrex, Inc.
Immunology · 221d
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
K924119
Ventrex, Inc.
Immunology · 108d
Cleared Nov 30, 1992
VENTREX ALLERGEN DISC
K924209
Hycor Biomedical, Inc.
Immunology · 102d