K163544

Substantially Equivalent

Lumipulse G Prolactin

Applicant: Fujirebio Diagnostics,Inc.
Product code: JIT
Advisory panel: Clinical Chemistry
Date received: 2016-12-16
Decision date: 2017-01-12
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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