LFT — Fluorescent Immunoassay, Primidone Class II
FDA Device Classification
Classification Details
- Product Code
- LFT
- Device Class
- Class II
- Regulation Number
- 862.3680
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K950028 | sigma diagnostics | PRIMIDONE FPIA REAGENT SET AND CALIBRATORS | March 21, 1995 |
| K904683 | baxter healthcare | STRATUS PRIMIDONE FLUOROMETRIC ENZYME | November 28, 1990 |
| K895567 | tudor laboratories | PRIMIDONE (FPIA) KIT | October 20, 1989 |
| K852318 | roche diagnostic systems | COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS | June 25, 1985 |
| K842196 | american dade | STRATUS PRIMIDONE FLOROMETRIC ENZY | July 11, 1984 |
| K823741 | syva | ADVANCE EMIT-AED PRIMEDONE ASSAY | January 7, 1983 |
| K822229 | american diagnostic | PRIMIDONE FLUORESCENT IMMUNOASSAY | August 12, 1982 |
| K811007 | miles laboratories | AMES TDA TM PRIMIDONE TEST | April 29, 1981 |