510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OKMClass II

Antibodies, Outer-Membrane Proteins

21 CFR 866.5785 / Immunology
FDA source (opens on fda.gov)

OKM is the FDA product code for Antibodies, Outer-Membrane Proteins, a class II device type, regulated under 21 CFR 866.5785. FDA's definition for this code reads: "For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OKM
Device name
Antibodies, Outer-Membrane Proteins
FDA definition
For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease.
Regulation
21 CFR 866.5785
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 OKM

By decision year
1 clearance under product code OKM with a decision year between 2008 and 2008, 2008 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OKM by decision year
YearClearances
20081

Applicants with the most clearances

Product code OKM
Applicants holding the most 510(k) clearances under product code OKM
ApplicantClearances
Inova Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OKM.