510(k) K140589
K140589 is an FDA 510(k) premarket notification submitted by Mesa Laboratories, Inc. for the device "STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR". The FDA issued a decision of Substantially Equivalent on December 3, 2014. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Mesa Laboratories, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 3, 2014
- Date Received
- March 7, 2014
- 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