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
49–72 of 265
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 Nov 04, 1987
TOTAL IGE FAST (TM) TEST PACKAGE
K873998
3M Company
Immunology · 34d
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 03, 1986
3M IGG4 FAST TEST PACKAGE
K863794
3M Company
Immunology · 68d