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
145–168 of 268
Cleared Mar 04, 1987
D. FARINAE ALLERGEN DISC
K870597
Incstar Corp.
Immunology · 21d
Cleared Feb 13, 1987
CAT EPITHELIUM ALLERGEN DISC
K870264
Incstar Corp.
Immunology · 21d
Cleared Feb 12, 1987
ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST
K864104
3M Company
Immunology · 114d
Cleared Feb 12, 1987
ALLERGEN SPECIFIC IGG4 CONTROL SERA
K870153
3M Company
Immunology · 30d
Cleared Feb 06, 1987
ALLERGEN SPECIFIC CONTROLS
K870152
3M Company
Immunology · 24d
Cleared Dec 22, 1986
SPECIFIC IGE FAST(TM) TEST II
K863967
3M Company
Immunology · 73d
Cleared Dec 03, 1986
3M IGG4 FAST TEST PACKAGE
K863794
3M Company
Immunology · 68d
Cleared Oct 03, 1986
PHADEBAS RAST/PHADEZYM RAST ALLERTUBE
K863036
Pharmacia, Inc.
Immunology · 52d
Cleared Sep 17, 1986
PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA
K863355
Pharmacia, Inc.
Immunology · 19d
Cleared Sep 16, 1986
VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY
K862901
Ventrex Laboratories, Inc.
Immunology · 47d
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