FDA 510(k)

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)

K-번호: K233663 · 2023-12-13

신청자Siemens Healthcare Diagnostics Products GmbH

결정일2023-12-13

제품 코드CFN

자문 위원회IM

결정Substantially Equivalent

기기 요약

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. It received FDA 510(k) clearance on 2023-12-13 under 510(k) number K233663. The device is classified under product code CFN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)?

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) is a medical device that received FDA 510(k) clearance on 2023-12-13. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K233663.

When did N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) receive FDA 510(k) clearance?

N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) received FDA 510(k) clearance on 2023-12-13, under 510(k) number K233663.

Who is the listed applicant for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)?

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

What is the FDA product code for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM)?

The FDA product code for N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) is CFN.

Siemens Healthcare Diagnostics Products GmbH를 신청인으로 등재한 기타 기록

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