K983700
Substantially EquivalentMODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- JXN
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Somerville, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.