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FDA 510(k)

cobas Cdiff nucleic acid test for use on the cobas Liat System

K-Number: K212427 · 2021-10-20

ApplicantRoche Molecular Systems, Inc.
Decision Date2021-10-20
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

cobas Cdiff nucleic acid test for use on the cobas Liat System is a medical device manufactured by Roche Molecular Systems, Inc.. It received FDA 510(k) clearance on 2021-10-20 under approval number K212427. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the cobas Cdiff nucleic acid test for use on the cobas Liat System?

cobas Cdiff nucleic acid test for use on the cobas Liat System is a medical device that received FDA 510(k) clearance on 2021-10-20. It is manufactured by Roche Molecular Systems, Inc.. The 510(k) number is K212427.

When was cobas Cdiff nucleic acid test for use on the cobas Liat System approved by the FDA?

cobas Cdiff nucleic acid test for use on the cobas Liat System received FDA 510(k) clearance on 2021-10-20, under approval number K212427.

What company makes cobas Cdiff nucleic acid test for use on the cobas Liat System?

cobas Cdiff nucleic acid test for use on the cobas Liat System is manufactured by Roche Molecular Systems, Inc..

What is the FDA product code for cobas Cdiff nucleic acid test for use on the cobas Liat System?

The FDA product code for cobas Cdiff nucleic acid test for use on the cobas Liat System is OZN.

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Related Devices (Code: OZN)

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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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