510(k) Report

Devices descending from DEN030002

3 later devices reach Endotoxin Activity Assay (Eaa) Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040887B-R-a-H-M-S PCT LiaBrahms Aktiengesellschaft20052—
+2K070310B R a H M S PCT Sensitive Kryptor Test SystemBrahms Aktiengesellschaft20081—
+3K240041IVD CAPSULE PSP; abioSCOPEAbionic SA20240—