510(k) Report

Devices descending from K161375

4 later devices reach Alere i RSV, Alere i Instrument, Alere i RSV Control Swab Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc.20183—
+2K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+2K190204ID NOW Influenza A & B 2Alere Scarborough, Inc.20191—
+3K191534ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.20190—