510(k) DEN220042
DEN220042 is an FDA 510(k) premarket notification submitted by Terragene S.A. for the device "Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)". The FDA issued a decision of De Novo Granted on July 12, 2024. The device falls under product code QVB (Biological Sterilization Indicator With Indirect Growth Detection), a Class II device regulated under 21 CFR 880.2806. Terragene S.A. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- July 12, 2024
- Date Received
- July 1, 2022
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Biological Sterilization Indicator With Indirect Growth Detection
- Device Class
- Class II
- Regulation Number
- 880.2806
- Review Panel
- HO
- Submission Type
A biological sterilization indicator with indirect growth detection capabilities is a device intended for use by a healthcare provider to accompany products being sterilized through a sterilization process to monitor the adequacy of sterilization. Detection of surviving microorganisms is accomplished by a method other than direct detection of growth or growth products.