510(k) K212193
Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) by
Plasmapp Co,., Ltd.
— Product Code FRC
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 2021
- Date Received
- July 14, 2021
- 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