cobas HbA1c Test, cobas b 101 system— 510(k) K163633
Substantially EquivalentRoche Diagnostics Operations
FDA 510(k) clearance K163633 for cobas HbA1c Test, cobas b 101 system, Substantially Equivalent on 2017-07-28. Applicant: Roche Diagnostics Operations.
Clearance details
- Applicant
- Roche Diagnostics Operations
- Product code
- Code LCP
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.