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FDA 510(k)

NeoLSD MSMS kit

K-Number: K173829 · 2018-07-18

ApplicantWallac Oy, A Subsidiary of Perkinelmer
Decision Date2018-07-18
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 Wallac Oy, A Subsidiary of Perkinelmer. It received FDA 510(k) clearance on 2018-07-18 under 510(k) number K173829. 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 2018-07-18. The listed applicant is Wallac Oy, A Subsidiary of Perkinelmer. The 510(k) number is K173829.

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

NeoLSD MSMS kit received FDA 510(k) clearance on 2018-07-18, under 510(k) number K173829.

Who is the listed applicant for NeoLSD MSMS kit?

The FDA 510(k) record lists Wallac Oy, A Subsidiary of Perkinelmer 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.

Related Devices (Code: PQW)

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.

K190266NeoLSD MSMS KitPerkinelmer, 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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