Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Genetic Signatures Limited. It received FDA 510(k) clearance on 2024-05-29 under 510(k) 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. The listed applicant is Genetic Signatures Limited. The 510(k) number is K232672.

When did EasyScreen Gastrointestinal Parasite Detection Kit receive FDA 510(k) clearance?

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

Who is the listed applicant for EasyScreen Gastrointestinal Parasite Detection Kit?

The FDA 510(k) record lists Genetic Signatures Limited as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: PCH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253722LIAISON PLEX Gastrointestinal Flex AssayLuminex CorporationK254032QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251721Xpert GI PanelCepheidK252329QIAstat-Dx Gastrointestinal Panel 2; QIAstat-Dx GI Panel 2 Mini B&V; QIAstat-Dx GI Panel 2 Mini BQIAGEN GmbHK251993Panther Fusion GI Expanded Bacterial AssayHologic, Inc.K251868Panther Fusion GI Bacterial AssayHologic

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.

↑