510(k) K170426
K170426 is an FDA 510(k) premarket notification submitted by Andersen Sterilizers, Inc. for the device "AN85/AN86 EO Indicators". The FDA issued a decision of Substantially Equivalent on October 30, 2017. The device falls under product code JOJ (Indicator, Physical/Chemical Sterilization Process), a Class II device regulated under 21 CFR 880.2800. Andersen Sterilizers, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 2017
- Date Received
- February 13, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Indicator, Physical/Chemical Sterilization Process
- Device Class
- Class II
- Regulation Number
- 880.2800
- Review Panel
- HO
- Submission Type