COBAS INTEGRA 400/800 BILIRUBIN TOTAL— 510(k) K081193
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K081193 for COBAS INTEGRA 400/800 BILIRUBIN TOTAL, Substantially Equivalent on 2009-01-16. Applicant: Roche Diagnostics.
Clearance details
- Applicant
- Roche Diagnostics
- Product code
- Code CIG
- 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.