510(k) Report

Devices descending from K151464

8 later devices reach Alere i Influenza A & B, Alere i Instrument, Alere i Influenza A & B Control… through their predicates, nearest generation first.

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