510(k) K031880— AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL
Substantially EquivalentRoche Diagnostics Corp.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code JIX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.