COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS— 510(k) K936131
Substantially EquivalentRoche Diagnostic Systems, Inc.
FDA 510(k) clearance K936131 for COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS, Substantially Equivalent on 1994-03-11. Applicant: Roche Diagnostic Systems, Inc..
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code LGR
- 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.