OCN — Insulin Autoantibody Kit Class II
FDA product code OCN covers "Insulin Autoantibody Kit", a Class II medical device regulated under 21 CFR 866.5660. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OCN
- Device Class
- Class II
- Regulation Number
- 866.5660
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
The device is used for the semi-quantitative determination of insulin autoantibodies in human serum as an aid in the diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in patients who have not received insulin therapy.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K070183 | kronus market development associates | KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT | July 13, 2007 |