510(k) Report

Devices descending from K173653

3 later devices reach Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc.20222—
+2K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+2K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.202312