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
73–91 of 91
Cleared May 07, 1991
PYLORI-G FIAX TEST KIT
K905468
Whittaker Bioproducts, Inc.
Microbiology · 152d
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