FDA 510(k)

cobas BKV

K-Number: K203220 · 2021-01-29

Decision Date2021-01-29

Product CodeQLX

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

cobas BKV is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2021-01-29 under approval number K203220. The device is classified under product code QLX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas BKV?

cobas BKV is a medical device that received FDA 510(k) clearance on 2021-01-29. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K203220.

When was cobas BKV approved by the FDA?

cobas BKV received FDA 510(k) clearance on 2021-01-29, under approval number K203220.

What company makes cobas BKV?

cobas BKV is manufactured by Roche Molecular Systems, Inc..

What is the FDA product code for cobas BKV?

The FDA product code for cobas BKV is QLX.

Other Devices by Roche Molecular Systems, Inc.

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Related Devices (Code: QLX)

DEN200015cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control KitRoche Molecular Systems, Inc. K212778Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)Abbott Molecular, Inc. K243489Alinity m EBV (09N43-095)Abbott Molecular, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.