510(k) K100818— ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920

Substantially Equivalent

Meridian Bioscience, Inc.

Clearance details

Applicant: Meridian Bioscience, Inc.
Product code: Code OMN
Advisory panel: Microbiology
Date received: 2010-03-23
Decision date: 2010-07-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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