Source document or public record
FDA 510(k) K254139 — BioCode® Respiratory Pathogen Panel (RPP)
FDA 510(k) index record K254139. Device: BioCode® Respiratory Pathogen Panel (RPP). Applicant as listed: Applied BioCode, Inc.. Decision date: 2026-05-01.
Source
"device_name": "BioCode® Respiratory Pathogen Panel (RPP)"
This entry describes what the document covers; the document itself is the authority. Listing it is not agreement with its conclusions.
Review and references
Automated FDA record verification
2026-10-20
2026-10-20
professional use
FDA 510(k) public index record K254139.
Device name: BioCode® Respiratory Pathogen Panel (RPP). Applicant as listed: Applied BioCode, Inc..
Decision date: 2026-05-01. Decision wording: Substantially Equivalent.
Product code: OCC. Regulation: 21 CFR 866.3980. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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