K080003

Substantially Equivalent

BINAXNOW G6PD TEST

Applicant: Binax, Inc.
Product code: JBF
Advisory panel: Hematology
Date received: 2008-01-02
Decision date: 2008-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scarborough, ME, US

Download summary PDF View on FDA.gov ↗

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