510(k) Report

Devices descending from K141757

8 later devices reach Alere I Strep a through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173653Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc.20183—
+1K151690Alere i Instrument, Alere i Influenza A & B, Alere i Strep AAlere Scarborough, Inc.20154—
+2K220801ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2Abbott Diagnostics Scarborough, Inc.20222—
+2K173932Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2Alere Scarborough, Inc.20183—
+3K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.20260—
+3K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.202312
+3K190204ID NOW Influenza A & B 2Alere Scarborough, Inc.20191—
+4K191534ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.20190—