DHB · Class II · 21 CFR 866.5750

FDA Product Code DHB: System, Test, Radioallergosorbent (rast) Immunological

Leading manufacturers include Diagnostic Products Corp., 3M Company and Hycor Biomedical.

265
Total
265
Cleared
109d
Avg days
1977
Since
265 devices
25–48 of 265
Cleared Aug 15, 1995
ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN
K953014
Diagnostic Products Corp.
Immunology · 47d
Cleared Mar 21, 1995
LATEX (K82)
K931746
Diagnostic Products Corp.
Immunology · 712d
Cleared Mar 06, 1995
HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT
K943768
Diagnostic Products Corp.
Immunology · 216d
Cleared Dec 19, 1994
IMMULITE ALATOP ALLERGY SCREEN
K941564
Diagnostic Products Corp.
Immunology · 262d
Cleared Mar 22, 1994
ALATOP(R) MICROPLATE ALLERGY SCREEN
K935488
Diagnostic Products Corp.
Immunology · 127d
Cleared Nov 29, 1991
ABBOTT MATRIX AERO PLUS SYSTEM
K913150
Abbott Laboratories
Immunology · 136d
Cleared Nov 22, 1991
ALLERGY INFORMATION MANAGER
K912294
Diagnostic Products Corp.
Immunology · 186d
Cleared Apr 17, 1991
ALLERGEN MODULES FOR ALASTAT TM
K894227
Diagnostic Products Corp.
Immunology · 667d
Cleared Jan 30, 1991
SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE
K910075
Diagnostic Products Corp.
Immunology · 22d
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 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 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 Oct 27, 1988
MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10)
K883371
3M Company
Immunology · 78d
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
Cleared Aug 10, 1988
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.
K881899
Diagnostic Products Corp.
Immunology · 96d
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 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