510(k) K242453
Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2);Terragene® Bionova® Photon Process Challenge Device with moving-front integrator (PCD225-C) by
Terragene S.A.
— Product Code FRC
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 12, 2024
- Date Received
- August 19, 2024
- 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