510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K253318Substantially Equivalent

Clungene RSV Antigen Rapid Test

Hangzhou Clongene Biotech Co., Ltd., Hangzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K253318 is the FDA 510(k) clearance record for Clungene RSV Antigen Rapid Test, a class I device, cleared for Hangzhou Clongene Biotech Co., Ltd. on under FDA product code GQG (Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus). FDA records list 9 510(k) clearances for Hangzhou Clongene Biotech Co., Ltd., from to . As of , FDA records show no recalls naming K253318.

Clearance record

Decision date
Received
(122 days to decision)
Product code
GQG Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Regulation
21 CFR 866.3480
Device class
Class I
Review panel
Microbiology
Applicant
Hangzhou Clongene Biotech Co., Ltd. #1 Yichuang Rd., Yuhang District, Hangzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GQG

Trailing 12 months
1 clearance under product code GQG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GQG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260