510(k) Report

Devices descending from K141520

11 later devices reach Alere I Influenza a & B through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171641Accula Flu A/Flu B TestMesa Biotech, Inc.20180—
+1K151464Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc.20158—
+1K151690Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc.20154—
+2K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc.20183—
+2K163266Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i InstrumentAlere Scarborough, Inc.20167—
+3K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+3K190204ID NOW Influenza A & B 2Alere Scarborough, Inc.20191—
+3K171792Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab KitAlere Scarborough, Inc.201761
+4K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc.20222—
+4K191534ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.20190—
+5K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.202312