Class Class II
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K230404)
Description
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel by Biofire Diagnostics, LLC, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230404
Clearance Date2023-03-16
Clearance TypeSpecial
Product CodePCH
Regulation Number866.3990
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230404
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. BIOFIRE FILMARRAY Gastrointestinal (GI) Panel (K230404) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K160459 | FilmArray Gastrointestinal Panel (GI) for use with FilmArra... | Biofire Diagnostics, LLC | 2016 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2024 |
Trace the full predicate network for K230404
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.