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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 a medical device manufactured by Wallac Oy, Subsidiary of Perkinelmer, Inc.. It received FDA 510(k) clearance on 2018-09-04 under approval 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. It is manufactured by Wallac Oy, Subsidiary of Perkinelmer, Inc.. The 510(k) number is K173568.

When was NeoBase 2 Non-derivatized MSMS Kit approved by the FDA?

NeoBase 2 Non-derivatized MSMS Kit received FDA 510(k) clearance on 2018-09-04, under approval number K173568.

What company makes NeoBase 2 Non-derivatized MSMS Kit?

NeoBase 2 Non-derivatized MSMS Kit is manufactured by Wallac Oy, Subsidiary of Perkinelmer, Inc..

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)

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.

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