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
121–144 of 269
Cleared Nov 21, 1990
ALRGN SET
K903637
Ciba Corning Diagnostics Corp.
Immunology · 100d
Cleared Oct 15, 1990
ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE
K903742
Diagnostic Products Corp.
Immunology · 61d
Cleared Sep 04, 1990
ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA
K902576
Diagnostic Products Corp.
Immunology · 85d
Cleared Jan 22, 1990
PHARMACIA CAP SYSTEM RAST RIA & RAST FEIA
K894190
Pharmacia, Inc.
Immunology · 220d
Cleared Jan 10, 1990
ENZYMUN TEST R IGE
K896902
Boehringer Mannheim Corp.
Immunology · 33d
Cleared Jan 10, 1990
3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8)
K897145
3M Company
Immunology · 14d
Cleared Dec 18, 1989
VENTREX COATED TUBE IGE ENZYME IMMUNOASSAY
K896852
Ventrex Laboratories, Inc.
Immunology · 13d
Cleared Dec 08, 1989
VENTREZYME VAST SPECIFIC IGE ASSAY
K896694
Ventrex Laboratories, Inc.
Immunology · 10d
Cleared Dec 04, 1989
CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY
K896592
Ciba Corning Diagnostics Corp.
Immunology · 13d
Cleared Jul 28, 1989
QUIDEL FOOD ALLERGEN SCREEN
K894253
Quidel Corp.
Immunology · 38d
Cleared Jun 02, 1989
PHADEBAS RAST(R)/PHADEZYM(R) RAST ALLERGEN DISC
K893132
Pharmacia, Inc.
Immunology · 38d
Cleared May 09, 1989
PHADIATOP PAEDIATRIC RIA AND EIA
K891135
Pharmacia, Inc.
Immunology · 67d
Cleared May 04, 1989
QUIDEL FOOD ALLERGEN SCREEN - BARLEY ALLERGEN
K892409
Quidel Corp.
Immunology · 27d
Cleared Feb 17, 1989
QUIDEL FOOD ALLERGY SCREEN
K884501
Quidel Corp.
Immunology · 114d
Cleared Feb 07, 1989
ADDIT. ALLERGENS TO INCLUDE FOODS FOR ALLERG*ENS
K885269
Dexall Biomedical Labs, Inc.
Immunology · 47d
Cleared Jan 23, 1989
28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM)
K884883
Diagnostic Products Corp.
Immunology · 62d
Cleared Jan 11, 1989
MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM)
K884923
Diagnostic Products Corp.
Immunology · 47d
Cleared Jan 04, 1989
IGE FASTSCREEN S6 (F1, F2, F4, F13, F14)
K885065
3M Company
Immunology · 29d
Cleared Nov 04, 1988
QM300 CONTROL E
K883537
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 78d
Cleared Oct 27, 1988
MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10)
K883371
3M Company
Immunology · 78d
Cleared Oct 27, 1988
CIBA CORNING MAGIC LITE TOTAL IGE IMMUNOASSAY
K884185
Ciba Corning Diagnostics Corp.
Immunology · 23d
Cleared Oct 18, 1988
QUIDEL ALLERGY SCREEN
K883666
Quidel Corp.
Immunology · 53d
Cleared Sep 22, 1988
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM)
K883616
Diagnostic Products Corp.
Immunology · 29d
Cleared Sep 07, 1988
DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13)
K883273
3M Company
Immunology · 35d