510(k) Report

Devices descending from DEN120001

2 later devices reach Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173704ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control…Phadia AB20180—
+1K132344E-Z Check Ozone Test StripsReprocessing Products Corporation (Rpc)20140—