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. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Operations
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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