LYR · Class I · 21 CFR 866.3110

FDA Product Code LYR: Helicobacter Pylori

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

91
Total
91
Cleared
165d
Avg days
1988
Since
91 devices
25–48 of 91
Cleared Sep 22, 1998
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
K980798
Princeton BioMeditech Corp.
Microbiology · 204d
Cleared Jul 30, 1998
HELICOBACTER PYLORI IGG ELISA TEST SYSTEM
K980821
Zeus Scientific, Inc.
Microbiology · 149d
Cleared May 12, 1998
PREMIER PLATINUM HPSA
K980076
Meridian Diagnostics, Inc.
Microbiology · 124d
Cleared Mar 03, 1998
ACCUSTAT H. PYLORI ONE STEP TEST
K973523
Boehringer Mannheim Corp.
Microbiology · 167d
Cleared Jan 21, 1997
IMMUNOCARD H. PYLORI
K961508
Meridian Diagnostics, Inc.
Microbiology · 277d
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 07, 1996
FLEXSURE HP,CONTROLS FOR FLEXSUREHP,FLEXPACK HP(ABBOTT DIAGNOSTICS)ANDCONTROLS FOR FLEXPACK HP (ABBOTT DIAGNOSTICS)
K960183
Smithkline Diagnostics, Inc.
Microbiology · 143d
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 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 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 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
QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR
K905049
Quidel Corp.
Microbiology · 180d
Cleared Apr 17, 1991
QUIDEL HELICOBACTER PYLORI TEST
K903099
Quidel Corp.
Microbiology · 278d
Cleared May 04, 1989
SELECTIVE RAPID UREA
K883641
Remel Co.
Microbiology · 252d