K232672
- 510(k) number
- K232672
- Device name
- EasyScreen Gastrointestinal Parasite Detection Kit
- Applicant
- Genetic Signatures Limited AU
- Product code
- PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Ac
- Decision date
- 2024-05-29
- Date received
- 2023-09-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K232672.pdf
Official FDA record: K232672
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.