510(k) K200970
K200970 is an FDA 510(k) premarket notification submitted by True Indicating, LLC for the device "Self-Contained Biological Indicator". The FDA issued a decision of Substantially Equivalent on December 28, 2020. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. True Indicating, LLC has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 28, 2020
- Date Received
- April 13, 2020
- 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