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
145–168 of 269
Cleared Aug 10, 1988
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.
K881899
Diagnostic Products Corp.
Immunology · 96d
Cleared Jun 14, 1988
HOUSE DUST
K875110
Incstar Corp.
Immunology · 183d
Cleared May 16, 1988
PHARMACIA IGG RAST RIA/PHARMACIA IGG RAST EIA
K880899
Pharmacia, Inc.
Immunology · 75d
Cleared May 11, 1988
MARSH ELDER ALLERGEN DISC
K874540
Incstar Corp.
Immunology · 190d
Cleared May 11, 1988
WALNUT ALLERGEN DISC
K874883
Incstar Corp.
Immunology · 162d
Cleared May 11, 1988
INCSTAR'S BIRCH ALLERGEN DISC
K880168
Incstar Corp.
Immunology · 117d
Cleared May 11, 1988
INCSTAR'S PIGWEED ALLERGEN DISC
K880221
Incstar Corp.
Immunology · 112d
Cleared Apr 21, 1988
GOLDENROD ALLERGEN DISC
K875163
Incstar Corp.
Immunology · 127d
Cleared Apr 21, 1988
ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM
K875244
Diagnostic Products Corp.
Immunology · 121d
Cleared Apr 21, 1988
DPC'S ALLERGEN-SPECIFIC IGE SYSTEM
K880160
Diagnostic Products Corp.
Immunology · 99d
Cleared Apr 21, 1988
INCSTAR'S DANDELION ALLERGEN DISC
K880187
Incstar Corp.
Immunology · 97d
Cleared Apr 21, 1988
MESQUITE ALLERGEN DISC
K880415
Incstar Corp.
Immunology · 80d
Cleared Apr 21, 1988
WHITE ASH ALLERGEN DISC
K880567
Incstar Corp.
Immunology · 71d
Cleared Apr 07, 1988
IVT CENTRAL ALLERGY SCREEN
K875329
In Vitro Technologies, Inc.
Immunology · 99d
Cleared Apr 06, 1988
QUIDEL ALLERGY SCREEN
K874717
Quidel Corp.
Immunology · 141d
Cleared Mar 25, 1988
VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY
K880547
Ventrex Laboratories, Inc.
Immunology · 45d
Cleared Mar 23, 1988
IVT WESTERN ALLERGY SCREEN
K875328
In Vitro Technologies, Inc.
Immunology · 84d
Cleared Mar 18, 1988
QUIDEL TOTAL IGE TEST
K875168
Quidel Corp.
Immunology · 93d
Cleared Mar 11, 1988
ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST
K880003
Em Diagnostic Systems, Inc.
Immunology · 67d
Cleared Feb 25, 1988
PROGENE(TM) IGE TEST
K875125
Progene Corp.
Immunology · 72d
Cleared Feb 25, 1988
MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3
K880001
3M Company
Immunology · 52d
Cleared Feb 17, 1988
FLIPSCREEN QAT
K874802
Alerchek, Inc.
Immunology · 86d
Cleared Feb 17, 1988
TOTAL IGE IMMUNO RESPONSE TEST (IRT(R))
K875274
Incstar Corp.
Immunology · 55d
Cleared Feb 17, 1988
MULTI-ALLERGEN IGE FAST SCREEN (MOLDS)
K880002
3M Company
Immunology · 44d