Product code KLQ
- Device name
- Radioimmunoassay, Amikacin
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3035
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K052815 | QMS AMIKACIN REAGENTS | Seradyn, Inc. | 2005-11-01 |
| K033884 | RANDOX AMIKACIN | Randox Laboratories, Ltd. | 2004-06-09 |
| K955570 | INNOFLUOR AMIKACIN ASSAY SYSTEM | Oxis Intl., Inc. | 1996-02-09 |
| K903100 | INNOFLUOR (TM) AMIKACIN REAGENT SET | Innotron of Oregon, Inc. | 1990-08-09 |
| K894517 | FPR AMIKACIN KIT | Colony Laboratories, Inc. | 1989-09-28 |
| K852317 | COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR | Roche Diagnostic Systems, Inc. | 1985-06-25 |
| K843211 | AMIKACIN ANALYTICAL TEST PACK ACA | E.I. Dupont DE Nemours & Co., Inc. | 1984-09-12 |
| K841161 | IMMPULSE AMIKACIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-05-02 |
| K840193 | EMIT QST AMIKACIN ASSAY | Syva Co. | 1984-03-23 |
| K832336 | STRATUS AMIKACIN FLUOROMETRIC | American Dade | 1983-08-31 |
| K822657 | EMIT-AMD AMIKACIN ASSAY | Dade Behring, Inc. | 1982-09-28 |
| K821771 | MACRO-VUE CARD TEST, AMIKACIN | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-25 |
| K820781 | COAT-A-COUNT AMIKACIN IRA | Diagnostic Products Corp. | 1982-04-09 |
| K813541 | AMIKACIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-01-12 |
| K811026 | AMES TDA TM AMIKACIN TEST | Miles Laboratories, Inc. | 1981-04-29 |
| K802877 | AMIKACIN RIA KIT | Antibodies, Inc. | 1980-12-19 |
| K802669 | CYBREX AMIKACIN | Abbott Laboratories | 1980-11-12 |
| K801130 | AMES TDA AMIKACIN | Miles Laboratories, Inc. | 1980-05-28 |
| K800517 | TOBRAM E.R.A. TM | P-L Biochemicals, Inc. | 1980-03-20 |
| K780494 | AMIKACIN | Diagnostic Products Corp. | 1978-04-10 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740154103 | Alinity | ABBOTT LABORATORIES | 2018-12-31 |
| 00842768001543 | Syva® Emit® Amikacin Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00884883005983 | QMS Amikacin Immunoassay | Microgenics Corporation | 2016-09-24 |
| 00884883012660 | QMS Amikacin Assay | Microgenics Corporation | 2016-09-12 |
| 00380740011277 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |