FDA 510(k)

NeoBase 2 Non-derivatized MSMS Kit

K-Number: K173568 · 2018-09-04

ApplicantWallac Oy, Subsidiary of Perkinelmer, Inc.

Decision Date2018-09-04

Product CodeNQL

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: NQL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K193103NeoBase 2 Non-derivatized MSMS KitPerkinelmer, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.