510(k) K043529
- Device
- ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE
- Applicant
- ROCHE DIAGNOSTICS CORP.
- 510(k) number
- K043529
- Product code
- LNX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-04-08
- Date received
- 2004-12-21
- Regulation
- 510(k) Premarket Notification
- Classification name
- Medical Computers And Software
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Scott Thiel
- Address
- 9115 Hague Rd. Indianapolis IN US 46250 46250
FDA Registration Numbers#
- 3006400278
- 3008460104
- 3005853093
- 3025343017
- 3014174631
- 2032227
- 3007981285
- 3042952037
- 3008770957
- 3016540876
- 1313700
- 3016592682
- 3008810357
- 3013922904
- 2219920
- 3009864844
- 3015192982
- 3042027705
- 3005627859
- 3010817588
- 3012421607
- 1220477
- 3008824097
- 1220973
- 3017986070
- 3014585508
- 3005244943
- 3044561902
- 3013498633
- 3013756811
- 3016798778
- 3020976354
- 3011393376
- 3013530341
Source Documents#
Legacy Summary#
summary
FDA Review#
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