BioCode® Respiratory Pathogen Panel (RPP)— 510(k) K254139

Name: FDA 510(k) clearance K254139
Creator: U.S. Food and Drug Administration
Published: 2026-05-01

Substantially Equivalent

Applied BioCode, Inc.

FDA 510(k) clearance K254139 for BioCode® Respiratory Pathogen Panel (RPP), Substantially Equivalent on 2026-05-01. Applicant: Applied BioCode, Inc.. Device class: 2.

Clearance details

Applicant: Applied BioCode, Inc.
Product code: Code OCC
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2025-12-22
Decision date: 2026-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Applied BioCode, Inc.

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K242877 — BioCode Gastrointestinal Pathogen Panel (GPP)2025-01-10
K192485 — BioCode Respiratory Pathogen Panel (RPP)2019-12-23
K190585 — Biocode Gastrointestinal Pathogen Panel (GPP)2019-06-05
K180041 — BioCode Gastrointestinal Pathogen Panel (GPP)2018-09-28

Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.