K123986

Substantially Equivalent

ACTIM PROM

Applicant: Alere Scarborough, Inc.
Product code: OAM
Advisory panel: Clinical Chemistry
Date received: 2012-12-26
Decision date: 2014-01-09
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.