K013118

Substantially Equivalent

MODIFICATION TO ALPHA DX SYSTEM

Applicant: First Medical, Inc.
Product code: JHX
Advisory panel: Clinical Chemistry
Date received: 2001-09-18
Decision date: 2001-10-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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