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
193–216 of 269
Cleared May 01, 1987
IVT SOUTHWEST ALLERGY SCREEN
K870625
In Vitro Technologies, Inc.
Immunology · 77d
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 Apr 14, 1987
TOTAL IGE MASTICK
K870966
Mast Immunosystems
Immunology · 35d
Cleared Mar 24, 1987
VENTREX IP SPECIFIC E ENZYME IMMUNOASSAY
K870624
Ventrex Laboratories, Inc.
Immunology · 39d
Cleared Mar 17, 1987
ALLERG*ENS ENZYME IMMUNOASSAY KIT
K864696
Dexall Biomedical Labs, Inc.
Immunology · 106d
Cleared Mar 04, 1987
D. FARINAE ALLERGEN DISC
K870597
Incstar Corp.
Immunology · 21d
Cleared Feb 13, 1987
CAT EPITHELIUM ALLERGEN DISC
K870264
Incstar Corp.
Immunology · 21d
Cleared Feb 12, 1987
ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST
K864104
3M Company
Immunology · 114d
Cleared Feb 12, 1987
ALLERGEN SPECIFIC IGG4 CONTROL SERA
K870153
3M Company
Immunology · 30d
Cleared Feb 06, 1987
ALLERGEN SPECIFIC CONTROLS
K870152
3M Company
Immunology · 24d
Cleared Dec 22, 1986
SPECIFIC IGE FAST(TM) TEST II
K863967
3M Company
Immunology · 73d
Cleared Dec 15, 1986
BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT
K863743
Immuno Nuclear Corp.
Immunology · 82d
Cleared Dec 03, 1986
RAPID SPECIFIC IGE PROCEDURE
K863394
Allertec, Inc.
Immunology · 91d
Cleared Dec 03, 1986
3M IGG4 FAST TEST PACKAGE
K863794
3M Company
Immunology · 68d
Cleared Dec 01, 1986
ELM ALLERGEN DISC
K863973
Immuno Nuclear Corp.
Immunology · 48d
Cleared Oct 29, 1986
IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC
K863844
Immuno Nuclear Corp.
Immunology · 28d
Cleared Oct 03, 1986
PHADEBAS RAST/PHADEZYM RAST ALLERTUBE
K863036
Pharmacia, Inc.
Immunology · 52d
Cleared Oct 01, 1986
IMMUNO BIOTECH MUGWART ALLERGEN DISC
K863123
Immuno Nuclear Corp.
Immunology · 48d
Cleared Sep 17, 1986
PHADIOTOP (TM) RIA/PHADIOTOP (TM) EIA
K863355
Pharmacia, Inc.
Immunology · 19d
Cleared Sep 16, 1986
VENTRESCREEN II POLLENS ENZYME IMMUNOASSAY
K862901
Ventrex Laboratories, Inc.
Immunology · 47d
Cleared Sep 15, 1986
MEADOW FESCUE ALLERGEN DISC
K863098
Immuno Nuclear Corp.
Immunology · 33d
Cleared Aug 19, 1986
MAPLE ALLERGEN DISC
K862266
Immuno Nuclear Corp.
Immunology · 67d
Cleared Aug 15, 1986
RUSSIAN THISTLE ALLERGEN DISC
K862176
Immuno Nuclear Corp.
Immunology · 67d