OKM
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antibodies, Outer-Membrane Proteins
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5785
- Medical specialty
- Immunology
- Flags
- Third-party review eligible
- 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.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| QUANTA LITE OMP PLUS ELISA (K081248) | Inova Diagnostics, Inc. | 2008-10-27 |
Track OKM automatically
Every clearance here is in the API, with alerts when new ones post.