510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
OCNClass II

Insulin Autoantibody Kit

21 CFR 866.5660 / Immunology
FDA source (opens on fda.gov)

OCN is the FDA product code for Insulin Autoantibody Kit, a class II device type, regulated under 21 CFR 866.5660. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OCN
Device name
Insulin Autoantibody Kit
FDA 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.
Regulation
21 CFR 866.5660
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
1
Ingested recalls
0

Clearances, product code OCN

By decision year
1 clearance under product code OCN with a decision year between 2007 and 2007, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OCN by decision year
YearClearances
20071

Applicants with the most clearances

Product code OCN
Applicants holding the most 510(k) clearances under product code OCN
ApplicantClearances
Kronus Market Development Associates, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code