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FDA 510(k)

EasyScreen Gastrointestinal Parasite Detection Kit

K-Number: K232672 · 2024-05-29

ApplicantGenetic Signatures Limited
Decision Date2024-05-29
Product CodePCH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

EasyScreen Gastrointestinal Parasite Detection Kit is a medical device manufactured by Genetic Signatures Limited. It received FDA 510(k) clearance on 2024-05-29 under approval number K232672. The device is classified under product code PCH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EasyScreen Gastrointestinal Parasite Detection Kit?

EasyScreen Gastrointestinal Parasite Detection Kit is a medical device that received FDA 510(k) clearance on 2024-05-29. It is manufactured by Genetic Signatures Limited. The 510(k) number is K232672.

When was EasyScreen Gastrointestinal Parasite Detection Kit approved by the FDA?

EasyScreen Gastrointestinal Parasite Detection Kit received FDA 510(k) clearance on 2024-05-29, under approval number K232672.

What company makes EasyScreen Gastrointestinal Parasite Detection Kit?

EasyScreen Gastrointestinal Parasite Detection Kit is manufactured by Genetic Signatures Limited.

What is the FDA product code for EasyScreen Gastrointestinal Parasite Detection Kit?

The FDA product code for EasyScreen Gastrointestinal Parasite Detection Kit is PCH.

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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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