510(k) K250549
K250549 is an FDA 510(k) premarket notification submitted by The Binding Site Group , Ltd. for the device "Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit". The FDA issued a decision of Substantially Equivalent on May 23, 2025. The device falls under product code DFH (Kappa, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5550. The Binding Site Group , Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 2025
- Date Received
- February 25, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kappa, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5550
- Review Panel
- IM
- Submission Type