NeoBase 2 Non-derivatized MSMS Kit— 510(k) K173568

Name: FDA 510(k) clearance K173568
Creator: U.S. Food and Drug Administration
Published: 2018-09-04

Substantially Equivalent

Wallac Oy, Subsidiary of Perkinelmer, Inc.

FDA 510(k) clearance K173568 for NeoBase 2 Non-derivatized MSMS Kit, Substantially Equivalent on 2018-09-04. Applicant: Wallac Oy, Subsidiary of Perkinelmer, Inc.. Device class: 2.

Clearance details

Applicant: Wallac Oy, Subsidiary of Perkinelmer, Inc.
Product code: Code NQL
Device class: Class 2
Regulation: 21 CFR 862.1055
Advisory panel: Clinical Chemistry
Date received: 2017-11-20
Decision date: 2018-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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