Solana Trichomonas Assay
K-Number: K161182 · 2016-08-15
ApplicantQuidel Corporation
Decision Date2016-08-15
Product CodeOUY
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Solana Trichomonas Assay is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2016-08-15 under approval number K161182. The device is classified under product code OUY. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Solana Trichomonas Assay?
Solana Trichomonas Assay is a medical device that received FDA 510(k) clearance on 2016-08-15. It is manufactured by Quidel Corporation. The 510(k) number is K161182.
When was Solana Trichomonas Assay approved by the FDA?
Solana Trichomonas Assay received FDA 510(k) clearance on 2016-08-15, under approval number K161182.
What company makes Solana Trichomonas Assay?
Solana Trichomonas Assay is manufactured by Quidel Corporation.
What is the FDA product code for Solana Trichomonas Assay?
The FDA product code for Solana Trichomonas Assay is OUY.
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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.