510(k) Report

Devices descending from K111387

18 later devices reach Liat (TM) Influenza a / B Assay, Liat (TM) Analyzer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191729Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat SystemRoche Molecular Systems, Inc.20194—
+1K153544cobas Influenza A/B & RSV Nucleic Acid Test for Use on the cobas Liat SystemIquum, Inc.20164—
+1K141520Alere I Influenza a & BAlere Scarborough, Inc D/B/A Binax, Inc.2014113
+2K200065cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza…Roche Molecular Systems, Inc.20203—
+2K171641Accula Flu A/Flu B TestMesa Biotech, Inc.20180—
+2K151464Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc.20158—
+2K151690Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc.20154—
+3K260047cobas Strep A Nucleic acid test for use on the cobas Liat System (07341911190); cobas…Roche Molecular Systems, Inc.20260—
+3K210234cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20211—
+3K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc.20183—
+3K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc.20167—
+4K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+4K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, Inc.20220—
+4K190204ID NOW Influenza A & B 2Alere Scarborough, Inc.20191—
+4K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc.201761
+5K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc.20222—
+5K191534ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.20190—
+6K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.202312