510(k) K200536
K200536 is an FDA 510(k) premarket notification submitted by 3M Complany for the device "3MTM AttestTM Rapid 5 Steam-Plus Test Pack". The FDA issued a decision of Substantially Equivalent on Jun 1, 2020. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 1, 2020
- Date Received
- Mar 3, 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
- 510(k)