510(k) Report

Devices descending from K160447

8 later devices reach Calprest NG through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceALPCO20190—
+1K191592CalprestNG, EasyCalEurospital S.P.A.20190—
+1K181012BUHLMANN fCAL ELISABuhlmann Laboratories AG20183—
+1K170993QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash…Inova Diagnostics, Inc.20171—
+2K190784BUHLMANN fCAL turboBuhlmann Laboratories AG20192—
+2K180971QUANTA Flash Calprotectin and Fecal Extraction DeviceInova Diagnostics, Inc.20180—
+3K191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG20191—
+4K232057BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AG20240—