K254139
- 510(k) number
- K254139
- Device name
- BioCode® Respiratory Pathogen Panel (RPP)
- Applicant
- Applied BioCode, Inc. CA · US
- Product code
- OCC — Respiratory Virus Panel Nucleic Acid Assay System
- Decision date
- 2026-05-01
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K254139.pdf
Official FDA record: K254139
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.