510(k) K173519
K173519 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader". The FDA issued a decision of Substantially Equivalent on Apr 23, 2018. The device falls under product code FRC (Indicator, Biological Sterilization Process), a Class II device regulated under 21 CFR 880.2800. 3M Company has 334 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 23, 2018
- Date Received
- Nov 14, 2017
- 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)