LCE — Radioimmunoassay, Netilmicin (I-125) Class II
FDA product code LCE covers "Radioimmunoassay, Netilmicin (I-125)", a Class II medical device regulated under 21 CFR 862.3450. Submissions are reviewed by the Clinical Toxicology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LCE
- Device Class
- Class II
- Regulation Number
- 862.3450
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K833715 | syva | EMIT NETILMICIN ASSAY | December 27, 1983 |
| K832088 | miles laboratories | AMES TDA NETILMICIN TEST & SERUM | October 28, 1983 |
| K822941 | american diagnostic | NETILMICIN FLUORESCENT IMMUNOASSAY | October 26, 1982 |
| K821698 | abbott laboratories | TDX NETILMICIN | June 22, 1982 |
| K821399 | bd becton dickinson vacutainer systems preanalytic | MACRO-VUE CARD TEST, NETILMICIN | May 28, 1982 |
| K820324 | syva | EMIT AND NETILMICIN ASSAY | February 23, 1982 |