FDA 510(k)

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) 검사

K-번호: K200256 · 2021-07-02

결정일2021-07-02

제품 코드PDJ

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

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K200256. The device is classified under product code PDJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay?

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K200256.

When did ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay receive FDA 510(k) clearance?

ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay received FDA 510(k) clearance on 2021-07-02, under 510(k) number K200256.

Who is the listed applicant for ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay?

The FDA product code for ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay is PDJ.

Siemens Healthcare Diagnostics, Inc.를 신청인으로 등재한 기타 기록

K253528아테리카 IM CA 19-9 II K261364아테리카 CH 아세트아미노펜 2 (ACTM)K251998Atellica CH 디아조 전체 빌리루빈 (D_TBil)K251543Atellica® IM TSH3-Ultra II (TSH3ULII)K251630아테리카 IM 전체 PSA II (tPSAII)K250816ADVIA Centaur Anti-Thyroglobulin II (aTgII)

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