FDA Product Code LQP: Campylobacter Spp.
Leading manufacturers include Techlab, Inc., 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
Cleared
Jun 20, 2019
Campylobacter Chek
Techlab, Inc.
Microbiology
21d
Cleared
Jun 20, 2019
Campylobacter Quik Chek
Techlab, Inc.
Microbiology
20d
Cleared
Jan 22, 2018
CAMPYLOBACTER QUIK CHEK
Techlab, Inc.
Microbiology
111d
Cleared
Jan 22, 2018
CAMPYLOBACTER CHEK
Techlab, Inc.
Microbiology
111d
Cleared
Dec 11, 1986
BBL CAMPYSLIDE(TM) TEST
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology
57d
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.