FDA 510(k)

NeoLSD MSMS Kit

K-Number: K190266 · 2019-05-03

Decision Date2019-05-03

Product CodePQW

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

NeoLSD 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 2019-05-03 under 510(k) number K190266. The device is classified under product code PQW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NeoLSD MSMS Kit?

NeoLSD MSMS Kit is a medical device that received FDA 510(k) clearance on 2019-05-03. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K190266.

When did NeoLSD MSMS Kit receive FDA 510(k) clearance?

NeoLSD MSMS Kit received FDA 510(k) clearance on 2019-05-03, under 510(k) number K190266.

Who is the listed applicant for NeoLSD 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 NeoLSD MSMS Kit?

The FDA product code for NeoLSD MSMS Kit is PQW.

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 kit K193103NeoBase 2 Non-derivatized MSMS Kit K190335GSP Neonatal Total Galactose kit K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector

Related Devices (Code: PQW)

K173829NeoLSD MSMS kitWallac Oy, A Subsidiary of Perkinelmer

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.