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
121–144 of 268
Cleared Feb 17, 1989
QUIDEL FOOD ALLERGY SCREEN
K884501
Quidel Corp.
Immunology · 114d
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
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 06, 1988
QUIDEL ALLERGY SCREEN
K874717
Quidel Corp.
Immunology · 141d