510(k) Report

Devices descending from K061795

5 later devices reach Dimension Vista PBNP Flex Reagent Cartridge and Calibrator through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080578Dimension Vista N-Terminal Pro-Brain Natriuretic Peptide (PBNP) Flex Reagent Cartridge…Siemens Healthcare Diagnostics, Inc.20084—
+2K113373Dimension Vista Loci 9 Calibrator- Loci 9 CalSiemens Healthcare Diagnostics, Inc.20111—
+2K082680Loci N-Terminal Pro-Brain Natriuretic Peptide Calibrator, Model RC623Siemens Healthcare Diagnostics20080—
+2K082645Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (NTP) Flex Reagent Cartridge…Siemens Healthcare Diagnostics200801
+3K130698Dimension Vista Progesterone Calibrator (Prog Cal)Siemens Healthcare Diagnostics20130—