510(k) K192001
Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device by
Sterilucent, Inc.
— Product Code FRC
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2019
- Date Received
- July 26, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Biological Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type