510(k) Report

Devices descending from K000462

4 later devices reach Urine Phencyclidine (PCP) Screen Flex Reagent Cartridge, Catalog NO. DF 94A through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163220Atellica CH Phencyclidine (Pcp)Siemens Healthcare Diagnostics, Inc.20171—
+1K062128The Dimension Vista Flex Reagent Cartridges / Kit AssaysDade Behring, Inc.20061—
+2K222439Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc)Siemens Healthcare Diagnostics, Inc.20230—
+2K102045Dimension Visa HBA1C, Model K3105ASiemens Heatlhcare Diagnostics, Inc.201103