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 25, 1988
VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY
K880547
Ventrex Laboratories, Inc.
Immunology · 45d
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
MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3
K880001
3M Company
Immunology · 52d
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
Cleared Dec 30, 1987
MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL)
K874446
3M Company
Immunology · 63d
Cleared Dec 18, 1987
MEDIX BIOTECH IGE VISUAL SCREENING TEST KIT
K874281
Medix Biotech, Inc.
Immunology · 59d
Cleared Nov 25, 1987
LIVE OAK ALLERGEN DISC
K874440
Incstar Corp.
Immunology · 28d
Cleared Nov 04, 1987
GIANT RAGWEED ALLERGEN DISC
K873969
Incstar Corp.
Immunology · 36d
Cleared Nov 04, 1987
TOTAL IGE FAST (TM) TEST PACKAGE
K873998
3M Company
Immunology · 34d
Cleared Nov 04, 1987
FALSE RAGWEED ALLERGEN DISC
K874149
Incstar Corp.
Hematology · 22d
Cleared Nov 04, 1987
JOHNSON GRASS ALLERGEN DISC
K874150
Incstar Corp.
Immunology · 22d
Cleared Oct 20, 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC
K872946
Pharmacia, Inc.
Immunology · 84d
Cleared Oct 20, 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISC
K873112
Pharmacia, Inc.
Immunology · 71d
Cleared Oct 20, 1987
BERMUDA GRASS ALLERGEN DISC
K873770
Incstar Corp.
Immunology · 34d
Cleared Oct 20, 1987
IGE IMMUNO RESPONSE TEST (IRT) COMP. FOR MOD. RAST
K873814
Incstar Corp.
Immunology · 29d
Cleared Oct 08, 1987
PHADEBAS RAST/PHADEZYM RAST ALLERGEN DISCS
K873193
Pharmacia, Inc.
Immunology · 56d
Cleared Oct 08, 1987
BAHIA ALLERGEN DISC
K873648
Incstar Corp.
Immunology · 29d
Cleared Oct 07, 1987
MODIFIED PHADEBAS RAST/PHADEZYM RAST
K872280
Pharmacia, Inc.
Immunology · 113d
Cleared Oct 07, 1987
RED TOP ALLERGEN DISC
K873486
Incstar Corp.
Immunology · 37d
Cleared Oct 07, 1987
IGE IMMUNO RESPONSE TEST (IRT) CALIBRATOR UNIT
K873676
Incstar Corp.
Immunology · 23d
Cleared Sep 23, 1987
RRT SHORT RAGWEED TEST KIT
K873406
Incstar Corp.
Immunology · 29d
Cleared Jul 16, 1987
ALTERNARIA TENUIS ALLERGEN DISC
K871684
Incstar Corp.
Immunology · 78d