LET — Fluorescent Immunoassay, Phenobarbital Class II
FDA product code LET covers "Fluorescent Immunoassay, Phenobarbital", a Class II medical device regulated under 21 CFR 862.3660. Submissions are reviewed by the Clinical Toxicology panel. At least 8 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LET
- Device Class
- Class II
- Regulation Number
- 862.3660
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K901537 | pb diagnostic systems | MODIFIED OPUS PHENOBARBITAL TEST SYSTEM | June 12, 1990 |
| K865000 | sclavo | IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTS | February 6, 1987 |
| K842592 | miles laboratories | AMES TDA PHENOBARBITAL TEST | August 17, 1984 |
| K830701 | american dade | STRATUS PHENOBARBITAL FLUOROMETRIC ENZ | May 13, 1983 |
| K821408 | american diagnostic | PHENOBARBITAL FLUORESCENT IMMUNO | May 24, 1982 |
| K820188 | syva | PHENOBARBITAL ASSAY | February 5, 1982 |
| K810994 | miles laboratories | AMES TDA TM PHENOBARBITAL TEST | April 29, 1981 |
| K802255 | miles laboratories | AMES TDA PHENOBARBITAL TEST | September 26, 1980 |