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FDA 510(k)

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

K-Number: K202215 · 2020-09-02

ApplicantRoche Molecular Systems, Inc.
Decision Date2020-09-02
Product CodeQMI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2020-09-02 under approval number K202215. The device is classified under product code QMI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit?

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit is a medical device that received FDA 510(k) clearance on 2020-09-02. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K202215.

When was cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit approved by the FDA?

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit received FDA 510(k) clearance on 2020-09-02, under approval number K202215.

What company makes cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit?

cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit is manufactured by Roche Molecular Systems, Inc..

What is the FDA product code for cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit?

The FDA product code for cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit is QMI.

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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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