510(k) Report

Devices descending from DEN200015

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K212778Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085)…Abbott Molecular, Inc.20221—
+1K202215cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, Inc.20202—
+2K243489Alinity m EBV (09N43-095)Abbott Molecular, Inc.20250—
+2K203220cobas BKVRoche Molecular Systems, Inc.20211—
+3K241921Alinity m BKVAbbott Molecular, Inc.20250—