Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NeoLSD MSMS Kit

K-Number: K190266 · 2019-05-03

ApplicantPerkinelmer, Inc.
Decision Date2019-05-03
Product CodePQW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NeoLSD MSMS Kit is a medical device manufactured by Perkinelmer, Inc.. It received FDA 510(k) clearance on 2019-05-03 under approval 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. It is manufactured by Perkinelmer, Inc.. The 510(k) number is K190266.

When was NeoLSD MSMS Kit approved by the FDA?

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

What company makes NeoLSD MSMS Kit?

NeoLSD MSMS Kit is manufactured by Perkinelmer, Inc..

What is the FDA product code for NeoLSD MSMS Kit?

The FDA product code for NeoLSD MSMS Kit is PQW.

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 K193103NeoBase 2 Non-derivatized MSMS Kit K203035Eonis SCID-SMA kit

View all 8 devices →

Related Devices (Code: PQW)

DEN150035SEEKER SystemBaebies, Inc. K173829NeoLSD MSMS kitWallac Oy, A Subsidiary of Perkinelmer

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.

↑