KLB · Radioimmunoassay, Tobramycin
Clinical Toxicology · 21 CFR 862.3900 · Class 2
Overview
| Product Code | KLB |
|---|---|
| Device Name | Radioimmunoassay, 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 (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K060853 | ONLINE TDM TOBRAMYCIN | Roche Diagnostics Corp. | Jun 9, 2006 | SESE |
| K012312 | IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) | Diagnostic Products Corp. | Aug 20, 2001 | SESE |
| K003341 | EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS | Syva Co., Dade Behring, Inc. | Jan 22, 2001 | SESE |
| K904304 | DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD | E.I. Dupont DE Nemours & Co., Inc. | Oct 26, 1990 | SESE |
| K903192 | IL TOBRAMYCIN ASSAY | Instrumentation Laboratory CO | Aug 22, 1990 | SESE |
| K893913 | TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD | Technicon Instruments Corp. | Aug 21, 1989 | SESE |
| K882294 | EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY | Syva Co. | Jul 1, 1988 | SESE |
| K874223 | EMIT TOBRAMYCIN ASSAY | Syva Co. | Nov 13, 1987 | SESE |
| K854184 | IN-VITRO TEST DETERMINATION OF TOBRAMYCIN | Clinical Data, Inc. | Dec 4, 1985 | SESE |
| K852671 | ACA TOBRAMY-CIN ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | Jul 22, 1985 | SESE |
| K832763 | TOBRAMYCIN REAGENT | Biosan Laboratories, Inc. | Mar 23, 1984 | SESE |
| K832985 | TOBRAMYCIN ANALYTICAL TEST PACK-ACA | E.I. Dupont DE Nemours & Co., Inc. | Oct 27, 1983 | SESE |
| K822858 | COAT-A-COUNT TOBRAMYCIN RIA KIT | Diagnostic Products Corp. | Oct 18, 1982 | SESE |
| K813516 | MRI TOBRAMYCIN RIA KIT | Microanalytic Research, Inc. | Dec 29, 1981 | SESE |
| K812415 | KALLESTAD ANTISERA TO TOBRAMYCIN | Kallestad Laboratories, Inc. | Sep 9, 1981 | SESE |
| K810597 | MACRO-VUE CARD TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | Mar 17, 1981 | SESE |
| K810011 | GAMMA STICK 125-1 TOBRAMYCIN RIA KIT | Alpha Gamma Laboratory | Jan 28, 1981 | SESE |
| K800743 | TOBRAMYCIN RIA KIT | Antibodies, Inc. | Apr 16, 1980 | SESE |
| K791596 | FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY | Bio-Rad | Oct 17, 1979 | SESE |
| K791502 | QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO | Bio-Rad | Sep 4, 1979 | SESE |
Top Applicants
- Diagnostic Products Corp. — 3 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 3 clearances
- Bio-Rad — 2 clearances
- Syva Co. — 2 clearances
- Alpha Gamma Laboratory — 1 clearance
