FDA.report

510(k) K242877

Device
BioCode Gastrointestinal Pathogen Panel (GPP)
Applicant
Applied BioCode, Inc.
510(k) number
K242877
Product code
PCH
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-10
Date received
2024-09-23
Regulation
866.3990
Classification name
Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based 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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