BioCode Gastrointestinal Pathogen Panel (GPP)— 510(k) K180041

Name: FDA 510(k) clearance K180041
Creator: U.S. Food and Drug Administration
Published: 2018-09-28

Substantially Equivalent

Applied BioCode, Inc.

FDA 510(k) clearance K180041 for BioCode Gastrointestinal Pathogen Panel (GPP), Substantially Equivalent on 2018-09-28. Applicant: Applied BioCode, Inc.. Device class: 2.

Clearance details

Applicant: Applied BioCode, Inc.
Product code: Code PCH
Device class: Class 2
Regulation: 21 CFR 866.3990
Advisory panel: Microbiology
Date received: 2018-01-05
Decision date: 2018-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, US

Download summary PDF View on FDA.gov ↗

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