DEN220042
- 510(k) number
- DEN220042
- Device name
- Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
- Applicant
- Terragene S.A. AR
- Product code
- QVB — Biological Sterilization Indicator With Indirect Gro
- Decision date
- 2024-07-12
- Date received
- 2022-07-01
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- General Hospital
Official FDA record: DEN220042
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.