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FDA 510(k)

Solana C. difficile Assay

K-Number: K170491 · 2017-05-11

ApplicantQuidel Corporation
Decision Date2017-05-11
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Solana C. difficile Assay is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2017-05-11 under approval number K170491. 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 Solana C. difficile Assay?

Solana C. difficile Assay is a medical device that received FDA 510(k) clearance on 2017-05-11. It is manufactured by Quidel Corporation. The 510(k) number is K170491.

When was Solana C. difficile Assay approved by the FDA?

Solana C. difficile Assay received FDA 510(k) clearance on 2017-05-11, under approval number K170491.

What company makes Solana C. difficile Assay?

Solana C. difficile Assay is manufactured by Quidel Corporation.

What is the FDA product code for Solana C. difficile Assay?

The FDA product code for Solana C. difficile Assay is 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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