FDA 510(k)

Lumipulse G TSH-III Immunoreaction Cartridges

K-번호: K171103 · 2017-07-28

결정일2017-07-28

제품 코드JLW

자문 위원회CH

결정Substantially Equivalent

기기 요약

Lumipulse G TSH-III Immunoreaction Cartridges is the device name listed in this FDA 510(k) record. The listed applicant is Fujirebio Diagnostics,Inc.. It received FDA 510(k) clearance on 2017-07-28 under 510(k) number K171103. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Lumipulse G TSH-III Immunoreaction Cartridges?

Lumipulse G TSH-III Immunoreaction Cartridges is a medical device that received FDA 510(k) clearance on 2017-07-28. The listed applicant is Fujirebio Diagnostics,Inc.. The 510(k) number is K171103.

When did Lumipulse G TSH-III Immunoreaction Cartridges receive FDA 510(k) clearance?

Lumipulse G TSH-III Immunoreaction Cartridges received FDA 510(k) clearance on 2017-07-28, under 510(k) number K171103.

Who is the listed applicant for Lumipulse G TSH-III Immunoreaction Cartridges?

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

What is the FDA product code for Lumipulse G TSH-III Immunoreaction Cartridges?

The FDA product code for Lumipulse G TSH-III Immunoreaction Cartridges is JLW.

Fujirebio Diagnostics,Inc.를 신청인으로 등재한 기타 기록

K250925ADVIA Centaur 세포자극 단편 21-1 K242706Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio K192524Lumipulse G CA15-3 K192380ST AIA-PACK BNP K200997Lumipulse G CA19-9-N K190702Lumipulse G whole PTH

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