ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL— 510(k) K974840
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K974840 for ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL, Substantially Equivalent on 1998-04-24. Applicant: Roche Diagnostic Systems, Inc..
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code DJG
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Somerville, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.