FDA 510(k)

GSP Neonatal Total Galactose kit

K-Number: K190335 · 2019-11-06

Decision Date2019-11-06

Product CodeJIA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GSP Neonatal Total Galactose 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 2019-11-06 under 510(k) number K190335. The device is classified under product code JIA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSP Neonatal Total Galactose kit?

GSP Neonatal Total Galactose kit is a medical device that received FDA 510(k) clearance on 2019-11-06. The listed applicant is Perkinelmer, Inc.. The 510(k) number is K190335.

When did GSP Neonatal Total Galactose kit receive FDA 510(k) clearance?

GSP Neonatal Total Galactose kit received FDA 510(k) clearance on 2019-11-06, under 510(k) number K190335.

Who is the listed applicant for GSP Neonatal Total Galactose 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 GSP Neonatal Total Galactose kit?

The FDA product code for GSP Neonatal Total Galactose kit is JIA.

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 K190266NeoLSD MSMS Kit K161966PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector K161942PerkinElmer, XRpad2 3025 HWC-M Flat Panel Detector

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.