FDA 510(k)

Clungene RSV 항원 빠른 검사

K-번호: K253318 · 2026-01-30

결정일2026-01-30

제품 코드GQG

자문 위원회미 (Original text: MI)

결정대체적으로 동일

기기 요약

Clungene RSV Antigen Rapid Test is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K253318. The device is classified under product code GQG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Clungene RSV Antigen Rapid Test?

Clungene RSV Antigen Rapid Test is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Hangzhou Clongene Biotech Co., Ltd.. The 510(k) number is K253318.

When did Clungene RSV Antigen Rapid Test receive FDA 510(k) clearance?

Clungene RSV Antigen Rapid Test received FDA 510(k) clearance on 2026-01-30, under 510(k) number K253318.

Who is the listed applicant for Clungene RSV Antigen Rapid Test?

The FDA 510(k) record lists Hangzhou Clongene Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clungene RSV Antigen Rapid Test?

The FDA product code for Clungene RSV Antigen Rapid Test is GQG.

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