OCN · Class II · 21 CFR 866.5660

FDA Product Code OCN: Insulin Autoantibody Kit

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.

1
Total
1
Cleared
175d
Avg days
2007
Since

FDA 510(k) Cleared Insulin Autoantibody Kit Devices (Product Code OCN)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OCN - Regulatory Context