510(k) DEN220042
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.