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.

Leading manufacturers include Kronus Market Development Associates, Inc..

Total

Cleared

175d

Avg days

2007

Since

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

1 devices

1–1 of 1

Cleared Jul 13, 2007

KRONUS INSULIN AUTOANTIBODY (IAA) ASSAY KIT

K070183

Kronus Market Development Associates, Inc.

Immunology · 175d

About Product Code OCN - Regulatory Context

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Data Source

FDA 510(k) public files . 175,972 total devices indexed.

Latest clearance: Jul 13, 2007

Product Code Info

Code	OCN
Device class	Class II
CFR	21 CFR 866.5660
Panel	Immunology

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