510(k) K151725
K151725 is an FDA 510(k) premarket notification submitted by Advanced Sterilization Products for the device "STERRAD NX Sterilizer, STERRAD 100NX Sterilizer". The FDA issued a decision of Substantially Equivalent on January 13, 2016. The device falls under product code MLR (Sterilizer, Chemical), a Class II device regulated under 21 CFR 880.6860. Advanced Sterilization Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 13, 2016
- Date Received
- June 26, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Sterilizer, Chemical
- Device Class
- Class II
- Regulation Number
- 880.6860
- Review Panel
- HO
- Submission Type