FDA 510(k)

ARCHITECT Active-B12 (홀로트랜스코발라민)

K-번호: K233541 · 2024-07-31

결정일2024-07-31

제품 코드CDD

자문 위원회CH

결정Substantially Equivalent

기기 요약

ARCHITECT Active-B12 (Holotranscobalamin) is the device name listed in this FDA 510(k) record. The listed applicant is Axis-Shield Diagnostics, Ltd.. It received FDA 510(k) clearance on 2024-07-31 under 510(k) number K233541. The device is classified under product code CDD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ARCHITECT Active-B12 (Holotranscobalamin)?

ARCHITECT Active-B12 (Holotranscobalamin) is a medical device that received FDA 510(k) clearance on 2024-07-31. The listed applicant is Axis-Shield Diagnostics, Ltd.. The 510(k) number is K233541.

When did ARCHITECT Active-B12 (Holotranscobalamin) receive FDA 510(k) clearance?

ARCHITECT Active-B12 (Holotranscobalamin) received FDA 510(k) clearance on 2024-07-31, under 510(k) number K233541.

Who is the listed applicant for ARCHITECT Active-B12 (Holotranscobalamin)?

The FDA 510(k) record lists Axis-Shield Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARCHITECT Active-B12 (Holotranscobalamin)?

The FDA product code for ARCHITECT Active-B12 (Holotranscobalamin) is CDD.

Axis-Shield Diagnostics, Ltd.를 신청인으로 등재한 기타 기록

K253539Alere NT-proBNP for Alinity i K241176Alere NT-proBNP for Alinity i 재료 키트 K172133ADVIA Centaur Active-B12 (활성 transcobalamin) (AB12) 검사

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