GSP Neonatal Total Galactose kit
K-Number: K190335 · 2019-11-06
ApplicantPerkinelmer, Inc.
Decision Date2019-11-06
Product CodeJIA
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
GSP Neonatal Total Galactose kit is a medical device manufactured by Perkinelmer, Inc.. It received FDA 510(k) clearance on 2019-11-06 under approval 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. It is manufactured by Perkinelmer, Inc.. The 510(k) number is K190335.
When was GSP Neonatal Total Galactose kit approved by the FDA?
GSP Neonatal Total Galactose kit received FDA 510(k) clearance on 2019-11-06, under approval number K190335.
What company makes GSP Neonatal Total Galactose kit?
GSP Neonatal Total Galactose kit is manufactured by Perkinelmer, Inc..
What is the FDA product code for GSP Neonatal Total Galactose kit?
The FDA product code for GSP Neonatal Total Galactose kit is JIA.
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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.