OKM — Antibodies, Outer-Membrane Proteins Class II
FDA product code OKM covers "Antibodies, Outer-Membrane Proteins", a Class II medical device regulated under 21 CFR 866.5785. Submissions are reviewed by the Immunology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OKM
- Device Class
- Class II
- Regulation Number
- 866.5785
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Definition
For the detection of anti-outer membrane protein (anti-OMP) antibodies in human serum. To aid in the diagnosis of Crohn's Disease.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K081248 | inova diagnostics | QUANTA LITE OMP PLUS ELISA | October 27, 2008 |