FilmArray TF Control Panel M527— 510(k) K260577
Substantially EquivalentMaine Molecular Quality Controls, Inc.
FDA 510(k) clearance K260577 for FilmArray TF Control Panel M527, Substantially Equivalent on 2026-05-19. Applicant: Maine Molecular Quality Controls, Inc.. Device class: 2.
Summary
Maine Molecular Quality Controls filed the FilmArray TF Control Panel M527 under PMN, assayed external control material for microbiology nucleic acid amplification (NAT) assays. The record doesn't expand "TF".
Class II, 21 CFR 866.3920. Microbiology is both the classification panel and the review panel. It was a Traditional 510(k).
The company filed from Saco, Maine. The decision came 88 calendar days after receipt (February 20 to May 19, 2026).
Clearance details
- Applicant
- Maine Molecular Quality Controls, Inc.
- Product code
- Product code PMN
- Device class
- Class 2
- Regulation
- 21 CFR 866.3920
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Saco, ME, US
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