Clearance Summary
SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) received FDA 510(k) clearance under submission number K233611, sponsored by Maine Molecular Quality Controls, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2024-03-26.
- Submission: K233611
- Applicant / Sponsor: Maine Molecular Quality Controls, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.3920
- Decision date: 2024-03-26
Classification & Regulation
This clearance is catalogued under FDA product code PMN and 21 CFR 866.3920, within the Microbiology review panel as a Class II device.