510(k) Report

Devices descending from K091766

4 later devices reach Clearview Exact PBP2A Test, Model 891-000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K162385Rapidec Carba NPBiomerieux S.A.20172—
+1K121905Alere PBP2A TestAlere Scarborough, Inc.20120—
+2K191889NG-Test CARBA 5Ng Biotech20191—
+3K243499NG-Test® CTX-M MULTINg Biotech20250—