ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
FDA 510(k) clearance K043529 · decided 2005-04-08
Clearance details
- K-number
- K043529
- Device name
- ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-12-21
- Decision date
- 2005-04-08
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- NDC
- Device class
- 2
- Regulation number
- 868.1890
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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