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
169–192 of 268
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
Cleared Jun 08, 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K831442
Pharmacia, Inc.
Chemistry · 34d
Cleared Jun 08, 1983
NEIN ALLERGEN DISC IN VAST VENTREX TEST
K831554
Ventrex Laboratories, Inc.
Immunology · 26d
Cleared Apr 27, 1983
PHADEBAS & PHADEZYM RAST MIXED ALLERG
K831045
Pharmacia, Inc.
Immunology · 27d
Cleared Apr 27, 1983
NEW ALLERGEN DISC -VAST VENTEX ALLERGY
K831091
Ventrex Laboratories, Inc.
Immunology · 23d
Cleared Mar 24, 1983
PHADEBAS & PHADEZYM RAST TEST ALLERG
K823592
Pharmacia, Inc.
Immunology · 108d
Cleared Mar 10, 1983
PHADEBAS & PHADEZYM RAST ALLERGEN DISCS
K830155
Pharmacia, Inc.
Chemistry · 51d
Cleared Feb 07, 1983
RIASSIST RAST DATA REDUCTION/QUALITY
K830170
Ventrex Laboratories, Inc.
Chemistry · 20d
Cleared Jan 28, 1983
PHADEBAS & PHADEZYME RAST ALLERGEN DISC
K830096
Pharmacia, Inc.
Chemistry · 17d
Cleared Dec 15, 1982
ALLERCOAT ALLERGEN DISCS
K823470
Kallestad Laboratories, Inc.
Immunology · 23d
Cleared Aug 03, 1982
PHADEBAS RAST TEST
K822141
Pharmacia, Inc.
Immunology · 14d
Cleared Jun 23, 1982
VAST VENTREX ALLERGY SYSTEMS TESTS
K821451
Ventrex Laboratories, Inc.
Immunology · 40d
Cleared Apr 06, 1982
KALLESTAD RAST REAGENTS
K820029
Kallestad Laboratories, Inc.
Immunology · 91d
Cleared Sep 14, 1981
KALLESTAD 125I ANTISERUM TO HUMAN IGE
K812414
Kallestad Laboratories, Inc.
Chemistry · 24d
Cleared Mar 11, 1981
PHADEZYM RAST TEST
K810462
Pharmacia, Inc.
Immunology · 19d
Cleared Dec 02, 1980
PHADEBAS RAST TEST
K802556
Pharmacia, Inc.
Immunology · 47d
Cleared Sep 02, 1977
PHADEBAS RAST PENICLLOYL G/V TEST
K771578
Pharmacia, Inc.
Microbiology · 15d