ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
FDA 510(k) clearance K080227 · decided 2008-05-15
Clearance details
- K-number
- K080227
- Device name
- ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2008-01-30
- Decision date
- 2008-05-15
- Days to decision
- 106 days
- Clearance type
- Abbreviated
- Product code
- MRZ
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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No recalls on record reference this clearance.
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