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FDA 510(k)

cobas BKV

K-Number: K203220 · 2021-01-29

ApplicantRoche Molecular Systems, Inc.
Decision Date2021-01-29
Product CodeQLX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas BKV is the device name listed in this FDA 510(k) record. The listed applicant is Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2021-01-29 under 510(k) 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. The listed applicant is Roche Molecular Systems, Inc.. The 510(k) number is K203220.

When did cobas BKV receive FDA 510(k) clearance?

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

Who is the listed applicant for cobas BKV?

The FDA 510(k) record lists Roche Molecular Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for cobas BKV?

The FDA product code for cobas BKV is QLX.

Other records listing Roche Molecular Systems, Inc. as applicant

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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.

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