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
25–48 of 268
Cleared May 22, 2008
HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
K081217
Hycor Biomedical, Inc.
Immunology · 22d
Cleared Mar 05, 2008
HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200
K080322
Hycor Biomedical, Inc.
Immunology · 28d
Cleared Dec 17, 2002
IMMULITE 2000 ALLERGEN-SPECIFIC IGE
K023152
Diagnostic Products Corp.
Immunology · 85d
Cleared May 30, 2002
IMMULITE 2000 SPECIFIC ALLERGENS
K021206
Diagnostic Products Corp.
Immunology · 44d
Cleared May 30, 2002
IMMULITE 2000 MIXED ALLERGEN PANELS
K021208
Diagnostic Products Corp.
Immunology · 44d
Cleared Oct 19, 2001
IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS)
K013135
Diagnostic Products Corp.
Immunology · 30d
Cleared Oct 15, 2001
IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS)
K013134
Diagnostic Products Corp.
Immunology · 26d
Cleared Dec 17, 1998
ALASTAT MICROPLATE MIXED ALLERGEN PANELS
K983954
Diagnostic Products Corp.
Immunology · 42d
Cleared Feb 09, 1998
ALLERGAN IMMUNO CAP M4, M8, K70
K974350
Pharmacia, Inc.
Immunology · 82d
Cleared Sep 29, 1997
IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE
K973186
Diagnostic Products Corp.
Immunology · 35d
Cleared Sep 04, 1997
UNICAP PHADIATOP
K972364
Pharmacia, Inc.
Immunology · 71d
Cleared Jul 03, 1997
UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82
K972068
Pharmacia, Inc.
Immunology · 30d
Cleared May 21, 1997
HYCOR ALLERGEN DISC
K965094
Hycor Biomedical, Inc.
Immunology · 153d
Cleared Nov 18, 1996
IMMULITE LATEX-SPECIFIC IGE
K963245
Diagnostic Products Corp.
Immunology · 91d
Cleared Oct 10, 1996
SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS
K961889
Diagnostic Products Corp.
Immunology · 147d
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