FDA 510(k)

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe

K-번호: K191396 · 2019-07-26

결정일2019-07-26

제품 코드CJY

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

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe is the device name listed in this FDA 510(k) record. The listed applicant is HORIBA ABX SAS. It received FDA 510(k) clearance on 2019-07-26 under 510(k) number K191396. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe?

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe is a medical device that received FDA 510(k) clearance on 2019-07-26. The listed applicant is HORIBA ABX SAS. The 510(k) number is K191396.

When did Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe receive FDA 510(k) clearance?

Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe received FDA 510(k) clearance on 2019-07-26, under 510(k) number K191396.

Who is the listed applicant for Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe?

The FDA 510(k) record lists HORIBA ABX SAS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe?

The FDA product code for Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe is CJY.

HORIBA ABX SAS를 신청인으로 등재한 기타 기록

K260781Yumizen H550 K232946Yumizen H2500 K193649Yumizen C1200 Creatinine PAP K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M K192028Yumizen C1200 CRP K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor

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