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510(k) K253318

Clungene RSV Antigen Rapid Test by Hangzhou Clongene Biotech Co., Ltd. — Product Code GQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 2026
Date Received
September 30, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Device Class
Class I
Regulation Number
866.3480
Review Panel
MI
Submission Type

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