FDA 510(k)

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test

K-번호: K251040 · 2025-09-09

신청자Guangzhou Decheng Biotechnology Co., Ltd.

결정일2025-09-09

제품 코드LCX

자문 위원회CH

결정Substantially Equivalent

기기 요약

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test is the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-09 under 510(k) number K251040. The device is classified under product code LCX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test is a medical device that received FDA 510(k) clearance on 2025-09-09. The listed applicant is Guangzhou Decheng Biotechnology Co., Ltd.. The 510(k) number is K251040.

When did MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test receive FDA 510(k) clearance?

MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test received FDA 510(k) clearance on 2025-09-09, under 510(k) number K251040.

Who is the listed applicant for MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

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

What is the FDA product code for MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test?

The FDA product code for MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test is LCX.

Guangzhou Decheng Biotechnology Co., Ltd.를 신청인으로 등재한 기타 기록

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