LGI
3 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Fluorescence Polarization Immunoassay, Carbamazepine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3645
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE (K944063) | Sigma Diagnostics, Inc. | 1994-11-10 |
| AXSYM(TM) QUINIDINE (K940682) | Abbott Laboratories | 1994-06-21 |
| MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA (K900702) | Innotron of Oregon, Inc. | 1990-04-12 |
Track LGI automatically
Every clearance here is in the API, with alerts when new ones post.