Clearance Summary
Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH) received FDA 510(k) clearance under submission number DEN220042, sponsored by Terragene S.A.. The device was reviewed via the Direct premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2024-07-12.
- Submission: DEN220042
- Applicant / Sponsor: Terragene S.A.
- Clearance pathway: Direct
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2806
- Decision date: 2024-07-12
Classification & Regulation
This clearance is catalogued under FDA product code QVB and 21 CFR 880.2806, within the General Hospital review panel as a Class II device.