KLQ · Radioimmunoassay, Amikacin
Clinical Toxicology · 21 CFR 862.3035 · Class 2
Overview
| Product Code | KLQ |
|---|---|
| Device Name | Radioimmunoassay, Amikacin |
| Regulation | 21 CFR 862.3035 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
An amikacin test system is a device intended to measure amikacin, an aminoglycoside antibiotic drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of amikacin overdose and in monitoring levels of amikacin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 20)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K052815 | QMS AMIKACIN REAGENTS | Seradyn, Inc. | Nov 1, 2005 | SESE |
| K033884 | RANDOX AMIKACIN | Randox Laboratories, Ltd. | Jun 9, 2004 | SESE |
| K955570 | INNOFLUOR AMIKACIN ASSAY SYSTEM | Oxis Intl., Inc. | Feb 9, 1996 | SESE |
| K903100 | INNOFLUOR (TM) AMIKACIN REAGENT SET | Innotron of Oregon, Inc. | Aug 9, 1990 | SESE |
| K894517 | FPR AMIKACIN KIT | Colony Laboratories, Inc. | Sep 28, 1989 | SESE |
| K852317 | COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR | Roche Diagnostic Systems, Inc. | Jun 25, 1985 | SESE |
| K843211 | AMIKACIN ANALYTICAL TEST PACK ACA | E.I. Dupont DE Nemours & Co., Inc. | Sep 12, 1984 | SESE |
| K841161 | IMMPULSE AMIKACIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | May 2, 1984 | SESE |
| K840193 | EMIT QST AMIKACIN ASSAY | Syva Co. | Mar 23, 1984 | SESE |
| K832336 | STRATUS AMIKACIN FLUOROMETRIC | American Dade | Aug 31, 1983 | SESE |
| K822657 | EMIT-AMD AMIKACIN ASSAY | Dade Behring, Inc. | Sep 28, 1982 | SESE |
| K821771 | MACRO-VUE CARD TEST, AMIKACIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | Jun 25, 1982 | SESE |
| K820781 | COAT-A-COUNT AMIKACIN IRA | Diagnostic Products Corp. | Apr 9, 1982 | SESE |
| K813541 | AMIKACIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | Jan 12, 1982 | SESE |
| K811026 | AMES TDA TM AMIKACIN TEST | Miles Laboratories, Inc. | Apr 29, 1981 | SESE |
| K802877 | AMIKACIN RIA KIT | Antibodies, Inc. | Dec 19, 1980 | SESE |
| K802669 | CYBREX AMIKACIN | Abbott Laboratories | Nov 12, 1980 | SESE |
| K801130 | AMES TDA AMIKACIN | Miles Laboratories, Inc. | May 28, 1980 | SESE |
| K800517 | TOBRAM E.R.A. TM | P-L Biochemicals, Inc. | Mar 20, 1980 | SESE |
| K780494 | AMIKACIN | Diagnostic Products Corp. | Apr 10, 1978 | SESE |
Top Applicants
- Diagnostic Products Corp. — 2 clearances
- Miles Laboratories, Inc. — 2 clearances
- Abbott Laboratories — 1 clearance
- American Dade — 1 clearance
- American Diagnostic Corp. — 1 clearance
