K842314

Substantially Equivalent

DUOCLON COLOR-CEPT

Applicant
Organon, Inc.
Product code
JHJ
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walker, MI, US
Download summary PDF View on FDA.gov ↗

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