LYR · Class I · 21 CFR 866.3110

FDA Product Code LYR: Helicobacter Pylori

Leading manufacturers include Quidel Corp., Meridian Bioscience, Inc. and Meridian Diagnostics, Inc..

91
Total
91
Cleared
165d
Avg days
1988
Since
91 devices
49–72 of 91
Cleared Jan 27, 1997
H.PYLORI CONTROLS
K964675
Pyramid Biological Corp.
Microbiology · 67d
Cleared Jan 21, 1997
IMMUNOCARD H. PYLORI
K961508
Meridian Diagnostics, Inc.
Microbiology · 277d
Cleared Sep 17, 1996
MERETEK BREATH TEST FOR H.PYLORI COLLECTION KIT
K952220
Meretek Diagnostics, Inc.
Microbiology · 495d
Cleared Aug 30, 1996
VARELISA HELICOBACTER PYLORI ANTIBODIES
K953873
Elias U.S.A., Inc.
Microbiology · 379d
Cleared Jul 30, 1996
PYLORI IGG ELISA TEST SYSTEM
K961221
Armkel, LLC
Microbiology · 132d
Cleared Jun 27, 1996
ACCUMETER H. PYLORI TEST
K960478
Chemtrak, Inc.
Microbiology · 146d
Cleared Jun 07, 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
K960183
Smithkline Diagnostics, Inc.
Microbiology · 143d
Cleared May 21, 1996
HELISAL RAPID BLOOD TEST
K953686
Cortecs, Ltd.
Microbiology · 295d
Cleared Feb 09, 1996
HM-CAP EIA TEST (MODIFICATION)
K955085
Schiff & Co.
Microbiology · 106d
Cleared Feb 06, 1996
QUICKVUE ONE-STEP HELICOBACTOR PYLORI TEST
K952517
Quidel Corp.
Microbiology · 251d
Cleared Jan 30, 1996
HM-CAP CONTROL PANEL
K954926
E-Z-Em, Inc.
Microbiology · 96d
Cleared Dec 18, 1995
SERIM PYLORITEK TEST KIT
K953632
Serim Research Corp.
Microbiology · 151d
Cleared Mar 03, 1995
PREMIER(TM) H. PYLORY
K945558
Meridian Diagnostics, Inc.
Microbiology · 109d
Cleared Dec 08, 1994
IMMUNOCARD H. PYLORI
K941560
Meridian Diagnostics, Inc.
Microbiology · 251d
Cleared May 18, 1994
FLEXSURE HP
K934863
Smithkline Diagnostics, Inc.
Microbiology · 218d
Cleared Aug 10, 1993
UBI MAGIWEL(TM) HELICOBACTER PYLORI IGG
K924689
United Biotech, Inc.
Microbiology · 327d
Cleared Sep 11, 1992
PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED
K923445
Hycor Biomedical, Inc.
Microbiology · 65d
Cleared Feb 21, 1992
QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
K915851
Quidel Corp.
Microbiology · 56d
Cleared Oct 21, 1991
PYLORISET
K904655
Orion Diagnostica, Inc.
Microbiology · 374d
Cleared Oct 11, 1991
HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
K912255
Hycor Biomedical, Inc.
Microbiology · 142d
Cleared Sep 16, 1991
QUIDEL HELICOBACTER PYLORI MICROWELL EIA TEST
K912442
Quidel Corp.
Microbiology · 105d
Cleared Jun 10, 1991
EIA FOR DETECTION OF ANTIBODIES H. PYLORI
K905409
E-Z-Em, Inc.
Microbiology · 189d
Cleared May 07, 1991
PYLORI STAT TEST KIT
K904738
Whittaker Bioproducts, Inc.
Microbiology · 201d
Cleared May 07, 1991
QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR
K905049
Quidel Corp.
Microbiology · 180d