OKM · Class II · 21 CFR 866.5785

FDA Product Code OKM: Antibodies, Outer-membrane Proteins

For The Detection Of Anti-outer Membrane Protein (anti-omp) Antibodies In Human Serum. To Aid In The Diagnosis Of Crohn's Disease.

Leading manufacturers include Inova Diagnostics, Inc..

1
Total
1
Cleared
178d
Avg days
2008
Since

FDA 510(k) Cleared Antibodies, Outer-membrane Proteins Devices (Product Code OKM)

1 devices
1–1 of 1
Cleared Oct 27, 2008
QUANTA LITE OMP PLUS ELISA
K081248
Inova Diagnostics, Inc.
Immunology · 178d

About Product Code OKM - Regulatory Context