FDA 510(k)

NeoBase 2 Non-derivatized MSMS Kit

K-번호: K173568 · 2018-09-04

신청자Wallac Oy, Subsidiary of Perkinelmer, Inc.

결정일2018-09-04

제품 코드NQL

자문 위원회CH

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 Wallac Oy, Subsidiary of Perkinelmer, Inc.. It received FDA 510(k) clearance on 2018-09-04 under 510(k) number K173568. 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 2018-09-04. The listed applicant is Wallac Oy, Subsidiary of Perkinelmer, Inc.. The 510(k) number is K173568.

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 2018-09-04, under 510(k) number K173568.

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

The FDA 510(k) record lists Wallac Oy, Subsidiary of 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.

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NeoBase 2 Non-derivatized MSMS Kit

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: NQL)

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