KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT— 510(k) K070183
Substantially EquivalentKronus Market Development Associates, Inc.
FDA 510(k) clearance K070183 for KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT, Substantially Equivalent on 2007-07-13. Applicant: Kronus Market Development Associates, Inc.. Device class: 2.
Clearance details
- Applicant
- Kronus Market Development Associates, Inc.
- Product code
- Code OCN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boise, ID, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.