K190335

Substantially Equivalent

GSP Neonatal Total Galactose kit

Applicant: Perkinelmer, Inc.
Product code: JIA
Advisory panel: Clinical Chemistry
Date received: 2019-02-14
Decision date: 2019-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.