510(k) K181434
K181434 is an FDA 510(k) premarket notification submitted by Crosstex/Spsmedical, A Division Of Cantel Medical for the device "SporView Rapid Read Biological Indicator SteamPlus Test Pack". The FDA issued a decision of Substantially Equivalent on Nov 14, 2018. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Crosstex/Spsmedical, A Division Of Cantel Medical has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 14, 2018
- Date Received
- Jun 1, 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
- 510(k)