510(k) K182404
K182404 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products (Asp) for the device "STERRAD VELOCITY Biological Indicator". The FDA issued a decision of Substantially Equivalent on December 27, 2018. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Advanced Sterilization Products (Asp) has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 27, 2018
- Date Received
- September 4, 2018
- 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