510(k) Report

Devices descending from K202215

2 later devices reach cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203220cobas BKVRoche Molecular Systems, Inc.20211—
+2K241921Alinity m BKVAbbott Molecular, Inc.20250—