FDA 510(k) Applications for Medical Device Product Code "LQP"
(Campylobacter Spp.)

FDA 510(k) Number Applicant Device Name Decision Date
K982315 ALEXON - TREND, INC. PROSPECT CAMPYLOBACTER MICROPLATE ASSAY 11/18/1998
K210976 Meridian Bioscience, Inc. Curian Campy 12/23/2021
K090700 MERIDIAN BIOSCIENCE, INC. IMMUNOCARD STAT CAMPY, MODEL 751530 05/28/2009
K083464 MERIDIAN BIOSCIENCE, INC. PREMIER CAMPY, MODEL 618096 01/30/2009
K211342 Quidel Corporation Sofia 2 Campylobacter FIA 11/23/2021
K191456 Techlab, Inc Campylobacter Quik Chek 06/20/2019
K173219 Techlab, Inc. CAMPYLOBACTER CHEK 01/22/2018
K191442 Techlab, Inc. Campylobacter Chek 06/20/2019
K173217 Techlab, Inc. CAMPYLOBACTER QUIK CHEK 01/22/2018


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact