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
193–216 of 268
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 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 21, 1985
PHADEBAS RAST PHADEZYM RAST ALLERTUBES
K851273
Pharmacia, Inc.
Chemistry · 50d
Cleared Mar 21, 1985
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K845032
Pharmacia, Inc.
Chemistry · 84d
Cleared Jul 02, 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K842457
Pharmacia, Inc.
Immunology · 10d
Cleared May 11, 1984
VENTRESCREEN, MULTIPLE ALLERGEN DISCS
K841516
Ventrex Laboratories, Inc.
Immunology · 29d
Cleared Apr 18, 1984
PHADEBAS RAST PHADEZYM MIX ALLERG
K840670
Pharmacia, Inc.
Microbiology · 57d
Cleared Apr 17, 1984
PHADEBAS RAST TEST -ALLERGEN DISCS
K840876
Pharmacia, Inc.
Toxicology · 50d
Cleared Apr 02, 1984
RAST ALLERGO SORBENT TEST
K840537
Pharmacia, Inc.
Microbiology · 54d
Cleared Mar 09, 1984
ALLERCOAT MULTISCREEN DISCS
K840360
Kallestad Laboratories, Inc.
Immunology · 43d
Cleared Sep 20, 1983
VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD
K832217
Ventrex Laboratories, Inc.
Chemistry · 104d