K251526
- 510(k) number
- K251526
- Device name
- FilmArray GI Control Panel M238
- Applicant
- Maine Molecular Quality Controls, Inc. ME · US
- Product code
- PMN — Assayed External Control Material For Microbiology N
- Decision date
- 2025-08-14
- Date received
- 2025-05-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Microbiology
PDFDownload 510(k) SummaryArchived here · 1.4 MB · U.S. public domain
Also available from FDA: K251526.pdf
Official FDA record: K251526
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.