510(k) Report

Devices descending from K090191

4 later devices reach Handylab GBS Assay, Handylab Jaguar Instrument, Handylab Dna Extraction Strip… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173725NeuMoDx GBS AssayNeumodx Molecular, Inc.20180—
+1K111860BD Max GBS Assay, BD Max InstrumentBecton, Dickinson & CO201227
+2K170557GenePOC GBS LBGenepoc, Inc.20171—
+3K182467Simplexa GBS Direct, Simplexa GBS Positive Control PackDiasorin Molecular, LLC20180—