FDA 510(k)

NeoBase 2 Non-derivatized MSMS Kit

K-Number: K193103 · 2020-02-07

Decision Date2020-02-07

Product CodeNQL

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

NeoBase 2 Non-derivatized MSMS Kit is a medical device manufactured by Perkinelmer, Inc.. It received FDA 510(k) clearance on 2020-02-07 under approval number K193103. 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 2020-02-07. It is manufactured by Perkinelmer, Inc.. The 510(k) number is K193103.

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

NeoBase 2 Non-derivatized MSMS Kit received FDA 510(k) clearance on 2020-02-07, under approval number K193103.

What company makes NeoBase 2 Non-derivatized MSMS Kit?

NeoBase 2 Non-derivatized MSMS Kit is manufactured by 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.

Other Devices by Perkinelmer, Inc.

K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector DEN180056GSP Neonatal Creatine Kinase - MM kit K190335GSP Neonatal Total Galactose kit K190266NeoLSD MSMS Kit K203035Eonis SCID-SMA kit

View all 8 devices →

Related Devices (Code: NQL)

K173568NeoBase 2 Non-derivatized MSMS KitWallac Oy, Subsidiary of Perkinelmer, Inc.

Official Source

View on FDA Database →

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