K011843

Substantially Equivalent

GENZYME DIRECT-AMYLASE TEST REAGENT

Applicant: Genzyme Corp.
Product code: JFJ
Advisory panel: Clinical Chemistry
Date received: 2001-06-12
Decision date: 2001-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

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