LGI — Fluorescence Polarization Immunoassay, Carbamazepine Class II
FDA Device Classification
Classification Details
- Product Code
- LGI
- Device Class
- Class II
- Regulation Number
- 862.3645
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K944063 | sigma diagnostics | FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE | November 10, 1994 |
| K940682 | abbott laboratories | AXSYM(TM) QUINIDINE | June 21, 1994 |
| K900702 | innotron of oregon | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA | April 12, 1990 |