Solana Influenza A+B Assay
K-Number: K161814 · 2016-09-27
ApplicantQuidel Corporation
Decision Date2016-09-27
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Solana Influenza A+B Assay is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2016-09-27 under approval number K161814. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Solana Influenza A+B Assay?
Solana Influenza A+B Assay is a medical device that received FDA 510(k) clearance on 2016-09-27. It is manufactured by Quidel Corporation. The 510(k) number is K161814.
When was Solana Influenza A+B Assay approved by the FDA?
Solana Influenza A+B Assay received FDA 510(k) clearance on 2016-09-27, under approval number K161814.
What company makes Solana Influenza A+B Assay?
Solana Influenza A+B Assay is manufactured by Quidel Corporation.
What is the FDA product code for Solana Influenza A+B Assay?
The FDA product code for Solana Influenza A+B Assay is OCC.
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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.