LCR · Fluorescent Immunoassay, Tobramycin
Clinical Toxicology · 21 CFR 862.3900 · Class 2
Overview
| Product Code | LCR |
|---|---|
| Device Name | Fluorescent Immunoassay, Tobramycin |
| Regulation | 21 CFR 862.3900 |
| Device Class | Class 2 |
| Review Panel | Clinical Toxicology |
| 3rd-Party Reviewable | Yes |
Identification
A tobramycin test system is a device intended to measure tobramycin, an aminoglycoside antibiotic drug, in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of tobramycin overdose and in monitoring levels of tobramycin to ensure appropriate therapy.
Classification Rationale
Class II.
Recent Cleared Devices (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060998 | QMS TOBRAMYCIN | Seradyn, Inc. | Jul 21, 2006 | SESE |
| K974029 | ACS TOBRAMYCIN | Chiron Diagnostics Corp. | Feb 12, 1998 | SESE |
| K962818 | TOBRAMYCIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | Sep 13, 1996 | SESE |
| K952568 | BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT | Beckman Instruments, Inc. | Aug 8, 1995 | SESE |
| K911940 | OPUS(R) TOBRAMYCIN | Pb Diagnostic Systems, Inc. | Jul 1, 1991 | SESE |
| K911613 | VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 | Exmoor Plastics , Ltd. | Jun 28, 1991 | SESE |
| K854873 | INTRAOCULAR PRESSURE REDUCER | Mira, Inc. | Feb 4, 1986 | SESE |
| K850058 | DU PONT TOBRAMYCIN ASSAY REAGENTS | E.I. Dupont DE Nemours & Co., Inc. | Jan 18, 1985 | SESE |
| K840847 | IMMPULSE TOBRAMYCIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | Apr 4, 1984 | SESE |
| K832408 | STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM | American Dade | Aug 26, 1983 | SESE |
| K822197 | NEEDLE HOLDERS | Kelleher Corp. | Aug 16, 1982 | SESE |
| K821542 | VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA | Electro-Nucleonics Laboratories, Inc. | Jun 3, 1982 | SESE |
| K820130 | ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY | Syva Co. | Feb 5, 1982 | SESE |
| K813542 | TOBRAMYCIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | Jan 12, 1982 | SESE |
| K810941 | AMES TDA TOBRAMYCIN TEST | Miles Laboratories, Inc. | Apr 17, 1981 | SESE |
| K802668 | CYBREX TOBRAMYCIN | Abbott Laboratories | Nov 24, 1980 | SESE |
| K801308 | FIAX TEST KIT FOR TOBRAMYCIN QUANTITA | Intl. Diagnostic Technology | Jun 20, 1980 | SESE |
Top Applicants
- Abbott Laboratories — 1 clearance
- American Dade — 1 clearance
- American Diagnostic Corp. — 1 clearance
- Beckman Instruments, Inc. — 1 clearance
- Chiron Diagnostics Corp. — 1 clearance
