FDA 510(k)

NeoLSD MSMS Kit

K-번호: K190266 · 2019-05-03

결정일2019-05-03

제품 코드PQW

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

NeoLSD 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 2019-05-03 under 510(k) number K190266. The device is classified under product code PQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the NeoLSD MSMS Kit?

NeoLSD MSMS Kit is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K190266.

When did NeoLSD MSMS Kit receive FDA 510(k) clearance?

NeoLSD MSMS Kit received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190266.

Who is the listed applicant for NeoLSD 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 NeoLSD MSMS Kit?

The FDA product code for NeoLSD MSMS Kit is PQW.

Perkinelmer, Inc.를 신청인으로 등재한 기타 기록

K203035Eonis SCID-SMA kit K193103NeoBase 2 Non-derivatized MSMS Kit K190335GSP Neonatal Total Galactose kit K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector

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