KLQ — Radioimmunoassay, Amikacin Class II
FDA Device Classification
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 |