510(k) K254139

Device
BioCode® Respiratory Pathogen Panel (RPP)
Applicant
Applied BioCode, Inc.
510(k) number
K254139
Product code
OCC
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-01
Date received
2025-12-22
Regulation
866.3980
Classification name
Respiratory Virus Panel Nucleic Acid Assay System
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Alex Chang
Address
12130 Mora Dr. Unit 2 Santa Fe Springs CA US 90670 90670

FDA Registration Numbers

Source Documents

510(k) summary PDF

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