K043529 is an FDA 510(k) clearance for the ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE. This device is classified as a Calculator, Drug Dose (Class II - Special Controls, product code NDC).
Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on April 8, 2005, 108 days after receiving the submission on December 21, 2004.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 868.1890.
| 510(k) Number | K043529 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2004 |
| Decision Date | April 08, 2005 |
| Days to Decision | 108 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | NDC — Calculator, Drug Dose |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.1890 |