FilmArray TF Control Panel M527
FDA 510(k) clearance K260577 · decided 2026-05-19
Clearance details
- K-number
- K260577
- Device name
- FilmArray TF Control Panel M527
- Applicant
- Maine Molecular Quality Controls, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2026-02-20
- Decision date
- 2026-05-19
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- PMN
- Device class
- 2
- Regulation number
- 866.3920
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Saco, ME, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Maine Molecular Quality Controls
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.