Home / 510(k) Clearances / K250549

510(k) K250549

Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit by The Binding Site Group , Ltd. — Product Code DFH

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

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