FDA Product Code LQP: Campylobacter Spp.
Leading manufacturers include Meridian Bioscience, Inc. and Quidel Corporation.
12
Total
12
Cleared
101d
Avg days
1986
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Campylobacter Spp. Devices (Product Code LQP)
12 devices
Cleared
Dec 23, 2021
Curian Campy
Meridian Bioscience, Inc.
Microbiology
266d
Cleared
Nov 23, 2021
Sofia 2 Campylobacter FIA
Quidel Corporation
Microbiology
204d
About Product Code LQP - Regulatory Context
510(k) Submission Activity
12 total 510(k) submissions under product code LQP since 1986, with 12 receiving FDA clearance (average review time: 101 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
LQP devices are reviewed by the Microbiology panel. Browse all Microbiology devices →