510(k) K953847— ROCHE REAGENT FOR GLUCOSE
Substantially EquivalentRoche Diagnostic Systems, Inc.
Clearance details
- Applicant
- Roche Diagnostic Systems, Inc.
- Product code
- Code CFR
- Advisory panel
- Clinical Chemistry
- 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.