510(k) K152389
K152389 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "Optilite Hevylite IgM Kappa Kit; Optilite Hevylite IgM Lambda Kit". The FDA issued a decision of Substantially Equivalent on December 18, 2015. The device falls under product code PDE (Immunoglobulin M 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
- December 18, 2015
- Date Received
- August 24, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoglobulin M 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 IgM kappa concentration in human serum. The result is to be used with previously diagnosed igm Waldenstoms Macrolobulinaemia, in conjunction with other clinical and laboratory findings.