K970921

Substantially Equivalent

STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)

Applicant: Alko Diagnostic Corp.
Product code: JIX
Advisory panel: Clinical Chemistry
Date received: 1997-03-12
Decision date: 1997-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Holliston, MA, US

Download summary PDF View on FDA.gov ↗

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