510(k) K941440— COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS
Substantially EquivalentRoche Diagnostic Systems, Inc.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code LBZ
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Branchburg, NJ, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.