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 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
Cleared Jul 13, 1987
SWEET VERNAL ALLERGEN DISC
K871723
Incstar Corp.
Immunology · 70d
Cleared Jun 12, 1987
DELFIA(TM) HIGE KIT
K871599
Lkb Instruments, Inc.
Immunology · 49d
Cleared May 14, 1987
WESTERN RAGWEED ALLERGEN DISC
K871660
Incstar Corp.
Immunology · 16d
Cleared Apr 28, 1987
VENTRESCREEN CAT/DOG ALLERGY TEST KIT ENZYME IMMU.
K871331
Ventrex Laboratories, Inc.
Immunology · 25d
Cleared Apr 14, 1987
VENTRESCREEN MITE/MOLD ALLERGY TEST KIT ENZYME IM.
K870009
Ventrex Laboratories, Inc.
Immunology · 102d
Cleared Mar 24, 1987
VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY
K870624
Ventrex Laboratories, Inc.
Immunology · 39d