510(k) Report

Devices descending from K982315

4 later devices reach Prospect Campylobacter Microplate Assay through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090700Immunocard Stat Campy, Model 751530Meridian Bioscience, Inc.20091—
+1K083464Premier Campy, Model 618096Meridian Bioscience, Inc.20091—
+2K173219Campylobacter ChekTechlab, Inc.20180—
+2K173217Campylobacter Quik ChekTechlab, Inc.20180—