K842314
Substantially EquivalentDUOCLON 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
Data sourced from openFDA. This site is unofficial and independent of the FDA.