Class Class II
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid (K243885)
Description
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid by Biofire Diagnostics, LLC, an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243885
Clearance Date2025-01-16
Clearance TypeSpecial
Product CodePCH
Regulation Number866.3990
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243885
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 Mid (K243885) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242367 | BIOFIRE FILMARRAY Gastrointestinal (GI) Panel | Biofire Diagnostics, LLC | 2024 |
Trace the full predicate network for K243885
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.