ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM— 510(k) K080227
Substantially EquivalentRoche Diagnostics Corp.
FDA 510(k) clearance K080227 for ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM, Substantially Equivalent on 2008-05-15. Applicant: Roche Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- Roche Diagnostics Corp.
- Product code
- Code MRZ
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Indianapolis, IN, US
Recent devices under product code MRZ
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