510(k) K153560
K153560 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "Optilite Low Level Albumin Kit". The FDA issued a decision of Substantially Equivalent on August 25, 2016. The device falls under product code DCF (Albumin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 25, 2016
- Date Received
- December 14, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Albumin, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5040
- Review Panel
- IM
- Submission Type