EasyScreen Gastrointestinal Parasite Detection Kit— 510(k) K232672

Name: FDA 510(k) clearance K232672
Creator: U.S. Food and Drug Administration
Published: 2024-05-29

Substantially Equivalent

Genetic Signatures Limited

FDA 510(k) clearance K232672 for EasyScreen Gastrointestinal Parasite Detection Kit, Substantially Equivalent on 2024-05-29. Applicant: Genetic Signatures Limited. Device class: 2.

Clearance details

Applicant: Genetic Signatures Limited
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2023-09-01
Decision date: 2024-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newtown, AU

Download summary PDF View on FDA.gov ↗

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