Product code KLB
- Device name
- Radioimmunoassay, Tobramycin
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3900
- 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 |
|---|---|---|---|
| K060853 | ONLINE TDM TOBRAMYCIN | Roche Diagnostics Corp. | 2006-06-09 |
| K012312 | IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) | Diagnostic Products Corp. | 2001-08-20 |
| K003341 | EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORS | Syva Co., Dade Behring, Inc. | 2001-01-22 |
| K904304 | DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1990-10-26 |
| K903192 | IL TOBRAMYCIN ASSAY | Instrumentation Laboratory CO | 1990-08-22 |
| K893913 | TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD | Technicon Instruments Corp. | 1989-08-21 |
| K882294 | EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY | Syva Co. | 1988-07-01 |
| K874223 | EMIT TOBRAMYCIN ASSAY | Syva Co. | 1987-11-13 |
| K854184 | IN-VITRO TEST DETERMINATION OF TOBRAMYCIN | Clinical Data, Inc. | 1985-12-04 |
| K852671 | ACA TOBRAMY-CIN ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1985-07-22 |
| K832763 | TOBRAMYCIN REAGENT | Biosan Laboratories, Inc. | 1984-03-23 |
| K832985 | TOBRAMYCIN ANALYTICAL TEST PACK-ACA | E.I. Dupont DE Nemours & Co., Inc. | 1983-10-27 |
| K822858 | COAT-A-COUNT TOBRAMYCIN RIA KIT | Diagnostic Products Corp. | 1982-10-18 |
| K813516 | MRI TOBRAMYCIN RIA KIT | Microanalytic Research, Inc. | 1981-12-29 |
| K812415 | KALLESTAD ANTISERA TO TOBRAMYCIN | Kallestad Laboratories, Inc. | 1981-09-09 |
| K810597 | MACRO-VUE CARD TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1981-03-17 |
| K810011 | GAMMA STICK 125-1 TOBRAMYCIN RIA KIT | Alpha Gamma Laboratory | 1981-01-28 |
| K800743 | TOBRAMYCIN RIA KIT | Antibodies, Inc. | 1980-04-16 |
| K791596 | FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY | Bio-Rad | 1979-10-17 |
| K791502 | QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO | Bio-Rad | 1979-09-04 |
| K791435 | AMES TDA/TOBRAMYCIN | Miles Laboratories, Inc. | 1979-08-16 |
| K780934 | IN VITRO TOBRAMYCIN RIA KIT | Clinical Assays, Inc. | 1978-08-14 |
| K760967 | TOBRAMYCIN RIA KIT | Diagnostic Products Corp. | 1976-12-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336147948 | ONLINE TDM Tobramycin | Roche Diagnostics GmbH | 2020-03-05 |
| 00842768001062 | Syva® Emit® 2000 Tobramycin Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768023309 | Emit® 2000 Tobramycin Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414561677 | ADVIA® Chemistry TOB_2 Tobramycin_2 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630997930 | Tobramycin ONLINE TDM Tobramycin | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630998999 | Tobramycin | Roche Diagnostics GmbH | 2016-09-20 |