KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT— 510(k) K080159
Substantially EquivalentKronus Market Development Associates, Inc.
FDA 510(k) clearance K080159 for KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT, Substantially Equivalent on 2008-05-22. Applicant: Kronus Market Development Associates, Inc.. Device class: 2.
Clearance details
- Applicant
- Kronus Market Development Associates, Inc.
- Product code
- Code JZO
- Device class
- Class 2
- Regulation
- 21 CFR 866.5870
- 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.