510(k) K210277

3M Attest Rapid Readout Biological Indicator, 1295 by 3M Company — Product Code FRC

K210277 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M Attest Rapid Readout Biological Indicator, 1295". The FDA issued a decision of Substantially Equivalent on Mar 3, 2021. 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
Mar 3, 2021
Date Received
Feb 1, 2021
Clearance Type
Special
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)