FDA 510(k)

N 레이텍스 FLC 카파 검사, N 레이텍스 FLC 라마 검사

K-번호: K182098 · 2018-11-01

신청자Siemens Healthcare Diagnostics Products GmbH

결정일2018-11-01

제품 코드DFH

자문 위원회IM

결정대체적으로 동일

기기 요약

N Latex FLC kappa assay, N Latex FLC lambda assay 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 2018-11-01 under 510(k) number K182098. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the N Latex FLC kappa assay, N Latex FLC lambda assay?

N Latex FLC kappa assay, N Latex FLC lambda assay is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Siemens Healthcare Diagnostics Products GmbH. The 510(k) number is K182098.

When did N Latex FLC kappa assay, N Latex FLC lambda assay receive FDA 510(k) clearance?

N Latex FLC kappa assay, N Latex FLC lambda assay received FDA 510(k) clearance on 2018-11-01, under 510(k) number K182098.

Who is the listed applicant for N Latex FLC kappa assay, N Latex FLC lambda assay?

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 Latex FLC kappa assay, N Latex FLC lambda assay?

The FDA product code for N Latex FLC kappa assay, N Latex FLC lambda assay is DFH.

Siemens Healthcare Diagnostics Products GmbH를 신청인으로 등재한 기타 기록

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