FDA 510(k)

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest

K-번호: K243256 · 2025-01-16

결정일2025-01-16

제품 코드SCA

자문 위원회MI

결정Substantially Equivalent

기기 요약

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest is the device name listed in this FDA 510(k) record. The listed applicant is Wondfo USA Co, Ltd.. It received FDA 510(k) clearance on 2025-01-16 under 510(k) number K243256. The device is classified under product code SCA. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest?

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Wondfo USA Co, Ltd.. The 510(k) number is K243256.

When did WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest receive FDA 510(k) clearance?

WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest received FDA 510(k) clearance on 2025-01-16, under 510(k) number K243256.

Who is the listed applicant for WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest?

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

What is the FDA product code for WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest?

The FDA product code for WELLlife™ COVID-19 / Influenza A&B Home Test; WELLlife™ COVID-19 / Influenza A&B AntigenTest is SCA.

Wondfo USA Co, Ltd.를 신청인으로 등재한 기타 기록

K251563WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test

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