510(k) K070183
- Device
- KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT
- Applicant
- KRONUS MARKET DEVELOPMENT ASSOCIATES, INC.
- 510(k) number
- K070183
- Product code
- OCN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-07-13
- Date received
- 2007-01-19
- Regulation
- 866.5660
- Classification name
- Insulin Autoantibody Kit
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- HEATHER VIELE
- Address
- 12554 W. Bridger St. Suite 108 Boise ID US 83713 83713
FDA Registration Numbers#
- 3006371704
- 3006126537
- 3003834021
- 1819470
- 2025560
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
Decision Summary