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FDA 510(k)

NeoBase 2 Non-derivatized MSMS Kit

K-Number: K193103 · 2020-02-07

ApplicantPerkinelmer, Inc.
Decision Date2020-02-07
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 Perkinelmer, Inc.. It received FDA 510(k) clearance on 2020-02-07 under 510(k) 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. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K193103.

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 2020-02-07, under 510(k) number K193103.

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

The FDA 510(k) record lists 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.

Other records listing Perkinelmer, Inc. as applicant

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.

K203035Eonis SCID-SMA kitK190335GSP Neonatal Total Galactose kitK190266NeoLSD MSMS KitK161966PerkinElmer XRpad2 4336 HWC-M Flat Panel DetectorK161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector

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.

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.

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