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
49–72 of 269
Cleared Aug 24, 2007
IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01
K071913
Phadia AB
Immunology · 44d
Cleared Jan 23, 2006
OPTIGEN ALLERGEN SPECIFIC IGE ASSAY
K051677
Hitachi Chemical Diagnostics, Inc.
Immunology · 216d
Cleared Jun 09, 2005
MODIFICATION TO: UNICAP SPECIFIC IGE
K051218
Pharmacia Diagnostics AB
Immunology · 28d
Cleared Mar 21, 2003
CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82)
K030590
Hitachi Chemical Diagnostics, Inc.
Immunology · 24d
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 Apr 17, 2002
MYALLERGYTEST SYSTEM
K020387
Immunetech Corporation
Immunology · 71d
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 Feb 18, 2000
ALLERGEN IMMUNOCAP, MODELS C74, E89, EX2, EX70, EX71, EX73, FX8, FX9, FX10, FX16, FX73, I72, I75, I76, K71, K73, K81, K8
K000132
Pharmacia & Upjohn Co.
Immunology · 31d
Cleared Dec 01, 1999
ALLERGEN IMMUNDOCAP MODELC5, C6, C73, E201, E213, F50, F51,F54, F55, F56, F57, F58, F59, F60, F61, F205, F213, F218, F
K993388
Pharmacia & Upjohn Co.
Immunology · 54d
Cleared May 14, 1999
ALLERGEN IMMUNOCAP, MODELS E7, F93, F94, F95, F203, F204, F208, F209, F210, F214, F216, F235, F237, F242, F255, F259, F2
K991048
Pharmacia & Upjohn Co.
Immunology · 45d
Cleared Dec 17, 1998
ALASTAT MICROPLATE MIXED ALLERGEN PANELS
K983954
Diagnostic Products Corp.
Immunology · 42d
Cleared Sep 15, 1998
ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3
K982343
Pharmacia & Upjohn Co.
Immunology · 71d
Cleared Feb 09, 1998
ALLERGAN IMMUNO CAP M4, M8, K70
K974350
Pharmacia, Inc.
Immunology · 82d
Cleared Feb 09, 1998
ALLERGEN IMMUNOCAP F256,F245,F207,F202
K974580
Pharmacia & Upjohn Co.
Immunology · 63d
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 Dec 23, 1996
PHARMACIA CAP SYSTEM RAST FEIA
K962976
Pharmacia & Upjohn Co.
Immunology · 145d
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