FDA 510(k)

SEJOY hCG 단계별 임신 검사 테스트 스틱, SEJOY hCG 단계별 임신 검사 캐셋, SEJOY hCG 단계별 임신 검사 미드스트리밍

K-번호: K212447 · 2022-02-18

신청자Hangzhou Sejoy Electronics & Instruments Co., Ltd.

결정일2022-02-18

제품 코드LCX

자문 위원회CH [기업명]의 [제품명]은 미국 식품의약국(FDA)에서 510(k) 등록을 완료한 의료기기입니다. 이 제품은 [PMA] 및 [NCT] 등록을 완료하였으며, [PMID]로 확인할 수 있습니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL].

결정Substantially Equivalent

기기 요약

SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Sejoy Electronics & Instruments Co., Ltd.. It received FDA 510(k) clearance on 2022-02-18 under 510(k) number K212447. 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 SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream?

SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Hangzhou Sejoy Electronics & Instruments Co., Ltd.. The 510(k) number is K212447.

When did SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream receive FDA 510(k) clearance?

SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream received FDA 510(k) clearance on 2022-02-18, under 510(k) number K212447.

Who is the listed applicant for SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream?

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

What is the FDA product code for SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream?

The FDA product code for SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream is LCX.

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SEJOY hCG 단계별 임신 검사 테스트 스틱, SEJOY hCG 단계별 임신 검사 캐셋, SEJOY hCG 단계별 임신 검사 미드스트리밍

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: LCX)

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