510(k) Report

Devices descending from DEN060001

13 later devices reach Phical Test through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K182698LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration…DiaSorin, Inc.20181—
+1K130945CalprestEurospital S.P.A.201410—
+2K213858LIAISON Calprotectin, LIAISON Q.S.E.T. Device PlusDiaSorin, Inc.202201
+2K191589Calprest, EasyCalEurospital S.P.A.20190—
+2K160447Calprest NGEurospital S.P.A.20168—
+3K191807ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction DeviceALPCO20190—
+3K191592CalprestNG, EasyCalEurospital S.P.A.20190—
+3K181012BUHLMANN fCAL ELISABuhlmann Laboratories AG20183—
+3K170993QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash…Inova Diagnostics, Inc.20171—
+4K190784BUHLMANN fCAL turboBuhlmann Laboratories AG20192—
+4K180971QUANTA Flash Calprotectin and Fecal Extraction DeviceInova Diagnostics, Inc.20180—
+5K191718Buhlmann fCAL turbo and CALEX CapBuhlmann Laboratories AG20191—
+6K232057BÜHLMANN fCAL® turbo and CALEX® CapBühlmann Laboratories AG20240—