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
217–240 of 269
Cleared Aug 15, 1986
COTTONWOOD ALLERGEN DISC
K862265
Immuno Nuclear Corp.
Immunology · 63d
Cleared Aug 15, 1986
JUNE GRASS ALLERGEN DISC
K862938
Immuno Nuclear Corp.
Immunology · 11d
Cleared Aug 15, 1986
ORCHARD GRASS ALLERGEN DISC
K862939
Immuno Nuclear Corp.
Immunology · 11d
Cleared Jul 03, 1986
PERENNIAL RYE ALLERGEN DISC
K862173
Immuno Nuclear Corp.
Immunology · 24d
Cleared Jul 03, 1986
ENGLISH PLAINTAIN ALLERGEN DISC
K862264
Immuno Nuclear Corp.
Immunology · 20d
Cleared Jun 20, 1986
WHITE OAK ALLERGEN DISC
K862175
Immuno Nuclear Corp.
Immunology · 11d
Cleared May 15, 1986
SHORT RAGWEED ALLERGEN DISC
K854756
Immuno Nuclear Corp.
Immunology · 169d
Cleared Apr 25, 1986
PHADEBAS RAST/PHADEZYM RAST TEST ALLERGEN DISCS
K861184
Pharmacia, Inc.
Immunology · 25d
Cleared Apr 22, 1986
PHADEBAS RAST PHADEZYM RAST DISCS FX2,FX3 & FX5
K854865
Pharmacia, Inc.
Immunology · 144d
Cleared Apr 22, 1986
THABEST-IGE
K855053
Visual Diagnostics, Inc.
Immunology · 126d
Cleared Apr 22, 1986
FLIPSCREEN SPECIFIC E (PE, SE, NE, SW, NW) ASSAY
K860027
Alerchek, Inc.
Immunology · 109d
Cleared Feb 13, 1986
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K854939
Pharmacia, Inc.
Immunology · 65d
Cleared Nov 18, 1985
PHADEBAS RAST TEST ALLERGEN DISCS
K853969
Pharmacia, Inc.
Immunology · 53d
Cleared Oct 16, 1985
VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY
K850895
Ventrex Laboratories, Inc.
Immunology · 226d
Cleared Sep 19, 1985
ALLERCOAT ALLERGEN DISCS
K852794
Kallestad Laboratories, Inc.
Immunology · 80d
Cleared Sep 19, 1985
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K853456
Pharmacia, Inc.
Immunology · 34d
Cleared Jul 15, 1985
PHADEBAS RAST TEST ALLERGEN DISCS
K852189
Pharmacia, Inc.
Immunology · 56d
Cleared Jun 27, 1985
PHADEBAS RAST/PHADEZYM RAST ALLERTUBES
K852263
Pharmacia, Inc.
Immunology · 34d
Cleared May 28, 1985
ALLERGENETICS IGE FAST TEST
K851512
Allergenetics
Immunology · 43d
Cleared May 21, 1985
PHADEBAS RAST PHADEZYM RAST ALLERTUBES
K851273
Pharmacia, Inc.
Chemistry · 50d
Cleared Apr 12, 1985
MAST ALLERGY SYSTEM
K843694
Mast Immunosystems
Immunology · 205d
Cleared Apr 12, 1985
MAST LUMINESCENT ALLERGY SYSTEM
K844629
Mast Immunosystems
Immunology · 136d
Cleared Mar 21, 1985
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K845032
Pharmacia, Inc.
Chemistry · 84d
Cleared Oct 04, 1984
NEW ALLERG. COATED MICROFILTER WELL STRI
K843302
Diagnostic Reagent Tech.
Immunology · 42d