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510(k) K250249

Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System by Gold Standard Diagnostics, LLC — Product Code GMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2025
Date Received
January 27, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Nontreponemal, All
Device Class
Class II
Regulation Number
866.3820
Review Panel
MI
Submission Type

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