K242877
- 510(k) number
- K242877
- Device name
- BioCode Gastrointestinal Pathogen Panel (GPP)
- Applicant
- Applied BioCode, Inc. CA · US
- Product code
- PCH — Gastrointestinal Pathogen Panel Multiplex Nucleic Ac
- Decision date
- 2025-01-10
- Date received
- 2024-09-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K242877.pdf
Official FDA record: K242877
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.