FDA 510(k)

NeoBase 2 Non-derivatized MSMS Kit

K-번호: K193103 · 2020-02-07

결정일2020-02-07

제품 코드NQL

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

NeoBase 2 Non-derivatized MSMS Kit is the device name listed in this FDA 510(k) record. The listed applicant is Perkinelmer, Inc.. It received FDA 510(k) clearance on 2020-02-07 under 510(k) number K193103. The device is classified under product code NQL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the NeoBase 2 Non-derivatized MSMS Kit?

NeoBase 2 Non-derivatized MSMS Kit is a medical device that received FDA 510(k) clearance on 2020-02-07. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K193103.

When did NeoBase 2 Non-derivatized MSMS Kit receive FDA 510(k) clearance?

NeoBase 2 Non-derivatized MSMS Kit received FDA 510(k) clearance on 2020-02-07, under 510(k) number K193103.

Who is the listed applicant for NeoBase 2 Non-derivatized MSMS Kit?

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

What is the FDA product code for NeoBase 2 Non-derivatized MSMS Kit?

The FDA product code for NeoBase 2 Non-derivatized MSMS Kit is NQL.

Perkinelmer, Inc.를 신청인으로 등재한 기타 기록

K203035Eonis SCID-SMA kit K190335GSP Neonatal Total Galactose kit K190266NeoLSD MSMS Kit K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector

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