510(k) Report

Devices descending from K953362

6 later devices reach Premier Ehec through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121364Shiga Toxin Quik ChekTechlab Inc., Corporate Research Center20121—
+1K121411Shiga Toxin ChekTechlab Inc., Corporate Research Center20120—
+1K062546Immunocard Stat! Ehec, Model 751630Meridian Bioscience, Inc.20073—
+1K061889Biostar Oia ShigatoxInverness Medical-Biostar, Inc.200611
+2K222829Curian® Shiga ToxinMeridian Bioscience, Inc.20230—
+2K071799Modification to Biostar Oia ShigatoxIverness Medical Professional Diagnostics20070—