KLQ — Radioimmunoassay, Amikacin Class II
FDA product code KLQ covers "Radioimmunoassay, Amikacin", a Class II medical device regulated under 21 CFR 862.3035. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KLQ
- Device Class
- Class II
- Regulation Number
- 862.3035
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K052815 | seradyn | QMS AMIKACIN REAGENTS | November 1, 2005 |
| K033884 | randox laboratories | RANDOX AMIKACIN | June 9, 2004 |
| K955570 | oxis intl | INNOFLUOR AMIKACIN ASSAY SYSTEM | February 9, 1996 |
| K903100 | innotron of oregon | INNOFLUOR (TM) AMIKACIN REAGENT SET | August 9, 1990 |
| K894517 | colony laboratories | FPR AMIKACIN KIT | September 28, 1989 |
| K852317 | roche diagnostic systems | COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR | June 25, 1985 |
| K843211 | e.i. dupont de nemours and co | AMIKACIN ANALYTICAL TEST PACK ACA | September 12, 1984 |
| K841161 | paragon diagnostics | IMMPULSE AMIKACIN ASSAY REAGENTS | May 2, 1984 |
| K840193 | syva | EMIT QST AMIKACIN ASSAY | March 23, 1984 |
| K832336 | american dade | STRATUS AMIKACIN FLUOROMETRIC | August 31, 1983 |
| K822657 | dade behring | EMIT-AMD AMIKACIN ASSAY | September 28, 1982 |
| K821771 | bd becton dickinson vacutainer systems preanalytic | MACRO-VUE CARD TEST, AMIKACIN | June 25, 1982 |
| K820781 | diagnostic products | COAT-A-COUNT AMIKACIN IRA | April 9, 1982 |
| K813541 | american diagnostic | AMIKACIN FLUORESCENT IMMUNOASSAY | January 12, 1982 |
| K811026 | miles laboratories | AMES TDA TM AMIKACIN TEST | April 29, 1981 |
| K802877 | antibodies | AMIKACIN RIA KIT | December 19, 1980 |
| K802669 | abbott laboratories | CYBREX AMIKACIN | November 12, 1980 |
| K801130 | miles laboratories | AMES TDA AMIKACIN | May 28, 1980 |
| K800517 | p-l biochemicals | TOBRAM E.R.A. TM | March 20, 1980 |
| K780494 | diagnostic products | AMIKACIN | April 10, 1978 |