FDA Product Code LYR: Helicobacter Pylori
Leading manufacturers include Meridian Bioscience, Inc..
91
Total
91
Cleared
165d
Avg days
1988
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared Helicobacter Pylori Devices (Product Code LYR)
91 devices
About Product Code LYR - Regulatory Context
510(k) Submission Activity
91 total 510(k) submissions under product code LYR since 1988, with 91 receiving FDA clearance (average review time: 165 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
LYR devices are reviewed by the Microbiology panel. Browse all Microbiology devices →