510(k) K161508
K161508 is an FDA 510(k) premarket notification submitted by Beckman Coulter Ireland, Inc. for the device "Ceruloplasmin". The FDA issued a decision of Substantially Equivalent on January 9, 2017. The device falls under product code DDB (Ceruloplasmin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5210. Beckman Coulter Ireland, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 2017
- Date Received
- June 1, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ceruloplasmin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5210
- Review Panel
- IM
- Submission Type