Product code LCR
- Device name
- Fluorescent Immunoassay, 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 |
|---|---|---|---|
| K060998 | QMS TOBRAMYCIN | Seradyn, Inc. | 2006-07-21 |
| K974029 | ACS TOBRAMYCIN | Chiron Diagnostics Corp. | 1998-02-12 |
| K962818 | TOBRAMYCIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 |
| K952568 | BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT | Beckman Instruments, Inc. | 1995-08-08 |
| K911940 | OPUS(R) TOBRAMYCIN | Pb Diagnostic Systems, Inc. | 1991-07-01 |
| K911613 | VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.4 | Exmoor Plastics , Ltd. | 1991-06-28 |
| K854873 | INTRAOCULAR PRESSURE REDUCER | Mira, Inc. | 1986-02-04 |
| K850058 | DU PONT TOBRAMYCIN ASSAY REAGENTS | E.I. Dupont DE Nemours & Co., Inc. | 1985-01-18 |
| K840847 | IMMPULSE TOBRAMYCIN ASSAY REAGENTS | Paragon Diagnostics, Inc. | 1984-04-04 |
| K832408 | STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM | American Dade | 1983-08-26 |
| K822197 | NEEDLE HOLDERS | Kelleher Corp. | 1982-08-16 |
| K821542 | VIRGO IMMUNO-PRECIPITATION ASSAY TOBRA | Electro-Nucleonics Laboratories, Inc. | 1982-06-03 |
| K820130 | ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY | Syva Co. | 1982-02-05 |
| K813542 | TOBRAMYCIN FLUORESCENT IMMUNOASSAY | American Diagnostic Corp. | 1982-01-12 |
| K810941 | AMES TDA TOBRAMYCIN TEST | Miles Laboratories, Inc. | 1981-04-17 |
| K802668 | CYBREX TOBRAMYCIN | Abbott Laboratories | 1980-11-24 |
| K801308 | FIAX TEST KIT FOR TOBRAMYCIN QUANTITA | Intl. Diagnostic Technology | 1980-06-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 04260759931253 | VenSure Light Balloon Dilation System | Fiagon GmbH | 2022-10-14 |
| 00380740154141 | Alinity | ABBOTT LABORATORIES | 2018-12-12 |
| 00630414595962 | Atellica CH Tob | Siemens Healthcare Diagnostics Inc. | 2017-12-22 |
| 00884883011328 | QMS Tobramycin Immunoassay Calibrator Set | Microgenics Corporation | 2016-10-25 |
| 00842768005381 | Dimension® Flex® reagent cartridge TOBR | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015472 | Dimension Vista® Flex® reagent cartridge TOBR | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00884883012691 | QMS Tobramycin Assay | Microgenics Corporation | 2016-09-12 |
| 15099590222185 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 00380740013127 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |
| 00817470009521 | VENTERA | Smith & Nephew, Inc. | 2015-12-06 |