DGC · Class II · 21 CFR 866.5510

FDA Product Code DGC: Ige, Antigen, Antiserum, Control

Leading manufacturers include Pharmacia, Inc., Ventrex Laboratories, Inc. and Kallestad Laboratories, Inc..

114
Total
114
Cleared
65d
Avg days
1977
Since
114 devices
49–72 of 114
Cleared Jun 07, 1984
PHARMACIA IGE RIA
K841824
Pharmacia, Inc.
Immunology · 36d
Cleared Jun 07, 1984
PHADEBAS RAST PHADEZYM RAST ALLERGEN
K841829
Pharmacia, Inc.
Immunology · 35d
Cleared Jun 07, 1984
ALLERCOAT ALLERGEN DISCS
K842125
Kallestad Laboratories, Inc.
Immunology · 9d
Cleared Jun 01, 1984
VAST VENTREX RAST ALL
K841651
Ventrex Laboratories, Inc.
Immunology · 42d
Cleared May 21, 1984
PHADEXACT SERUM, TOTAL IGE CONTROLS
K840476
Pharmacia, Inc.
Chemistry · 108d
Cleared Apr 04, 1984
SENSIBEAD EIA IGE KIT
K840674
Terumo Medical Corp.
Immunology · 49d
Cleared Mar 23, 1984
PHADEXACT SERUM, ALLERGEN SPECIFIC IGE
K840538
Pharmacia, Inc.
Immunology · 44d
Cleared Oct 14, 1983
ABBOTT IGE EIA
K832360
Abbott Laboratories
Chemistry · 88d
Cleared Sep 20, 1983
ALLERGEN CONTROL INHALENT
K832218
Ventrex Laboratories, Inc.
Chemistry · 104d
Cleared Jun 02, 1983
ALLERCOAT ALLERGEN DISCS
K831326
Kallestad Laboratories, Inc.
Immunology · 38d
Cleared Jun 02, 1983
IGE RADIOIMMUNOASSAY KIT
K831377
American Diagnostic Corp.
Chemistry · 36d
Cleared Jun 02, 1983
VENTRE/ZYME IGE KIT
K831485
Ventrex Laboratories, Inc.
Immunology · 24d
Cleared May 09, 1983
IGE-QUANT DIAGNOSTIC TEST KIT
K831208
Leeco Diagnostics, Inc.
Chemistry · 25d
Cleared Apr 27, 1983
NEW ALLERGEN DISCS FOR USE IN VAST VENT
K830817
Ventrex Laboratories, Inc.
Immunology · 43d
Cleared Jan 12, 1983
PHADEBAS RAST ALLERGEN DISCS
K823841
Pharmacia, Inc.
Immunology · 22d
Cleared Jan 12, 1983
PHADEZYM RAST ALLERGEN DISCS
K823842
Pharmacia, Inc.
Immunology · 22d
Cleared Dec 28, 1982
TANDEM-E -IGE IMMUNOEZYMETRIC ASSAY
K823507
Hybritech, Inc.
Chemistry · 34d
Cleared Dec 15, 1982
ALLERCOAT POSITIVE CONTROL SERUM
K823403
Kallestad Laboratories, Inc.
Immunology · 30d
Cleared Oct 22, 1982
RAST ALLERCOAT ALLERGEN DISCS
K822613
Kallestad Laboratories, Inc.
Immunology · 53d
Cleared Sep 02, 1982
VAST VENTREX RAST ALLERGEN DISCS
K822442
Ventrex Laboratories, Inc.
Chemistry · 17d
Cleared Aug 16, 1982
TOTAL IGE DISCS
K822206
Kallestad Laboratories, Inc.
Chemistry · 21d
Cleared Jun 11, 1982
VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD
K820977
Ventrex Laboratories, Inc.
Microbiology · 66d
Cleared Jun 11, 1982
VENTRE/SPEC ALLERGEN CONTROL-INHALANT
K820978
Ventrex Laboratories, Inc.
Microbiology · 66d
Cleared Jun 10, 1982
VAST VENTREX PD IGE RIA TEST SET
K821615
Ventrex Laboratories, Inc.
Chemistry · 8d