510(k) K172613
K172613 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit". The FDA issued a decision of Substantially Equivalent on February 15, 2018. The device falls under product code PCN (Immunoglobulin G Kappa Heavy And Light Chain Combined), a Class II device regulated under 21 CFR 866.5510. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 2018
- Date Received
- August 31, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoglobulin G Kappa Heavy And Light Chain Combined
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type
Intended for the in-vitro quantification of IgG kappa concentration in human serum.