510(k) Report

Devices descending from K132843

2 later devices reach Verigene Gram Negative Blood Culture Nucleic Acid Test (BC-GN) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243013LIAISON PLEX Gram-Negative Blood Culture AssayLuminex Corporation20250—
+1K190341iC-GN iC-Cassette for use on the iC-SystemIcubate, Inc.20190—