Class Class II
FilmArray GI Control Panel M238 (K251526)
Description
FilmArray GI Control Panel M238 by Maine Molecular Quality Controls, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK251526
Clearance Date2025-08-14
Clearance TypeTraditional
Product CodePMN
Regulation Number866.3920
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251526
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. FilmArray GI Control Panel M238 (K251526) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202196 | BioFire RP2.1/RP2.1plus Control Panel M441 | Maine Molecular Quality Controls, Inc. | 2021 |
Trace the full predicate network for K251526
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.