Product code LCD
- Device name
- Enzyme Immunoassay, Gentamicin
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3450
- 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 |
|---|---|---|---|
| K243500 | ARCHITECT iGentamicin | Abbott Laboratories | 2025-07-09 |
| K102699 | ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS | Abbott Laboratories | 2011-04-01 |
| K060709 | MULTIGENT GENTAMICIN | Seradyn, Inc. | 2006-06-15 |
| K042479 | VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE | Ortho-Clinical Diagnostics, Inc. | 2005-01-06 |
| K020704 | ROCHE ONLINE GENTAMICIN | Roche Diagnostics Corp. | 2002-07-12 |
| K012978 | RANDOX GENTAMICIN | Randox Laboratories, Ltd. | 2001-09-18 |
| K012311 | IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) | Diagnostic Products Corp. | 2001-08-20 |
| K010984 | EMIT 2000 GENTAMICIN PLUS ASSAY | Syva Co., Dade Behring, Inc. | 2001-04-20 |
| K962819 | GENTAMICIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 |
| K962519 | EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS | Behring Diagnostics, Inc. | 1996-09-04 |
| K953020 | ACS GENTAMICIN | Ciba Corning Diagnostics Corp. | 1995-08-02 |
| K943982 | IL TEST GENTAMICIN CALIBRATORS | Instrumentation Laboratory CO | 1995-01-25 |
| K935376 | AXSYM GENTAMICIN | Abbott Mfg., Inc. | 1994-06-21 |
| K940376 | QMS GENTAMICIN ASSAY | Seradyn, Inc. | 1994-06-02 |
| K913470 | CEDIA(R) GENTAMICIN ASSAY | Microgenics Corp. | 1991-09-27 |
| K904305 | DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1990-10-15 |
| K903743 | IL GENTAMICIN ASSAY SYSTEM | Instrumentation Laboratory CO | 1990-09-17 |
| K900703 | MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | 1990-04-12 |
| K895484 | STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. | Baxter Healthcare Corp | 1989-10-04 |
| K893912 | TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD | Technicon Instruments Corp. | 1989-08-21 |
| K874703 | EMIT CONVENIENCE PACK: GENTAMICIN ASSAY | Syva Co. | 1987-12-18 |
| K873855 | EMIT QST GENTAMICIN ASSAY | Syva Co. | 1987-10-29 |
| K873854 | EMIT GENTAMICIN ASSAY | Syva Co. | 1987-10-28 |
| K871329 | EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640 | Em Diagnostic Systems, Inc. | 1987-05-12 |
| K862260 | EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS | Syva Co. | 1986-11-03 |
| K860868 | TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN | Technicon Instruments Corp. | 1986-04-03 |
| K860045 | DETERMINATION OF GENTAMICIN | Clinical Data, Inc. | 1986-01-22 |
| K852672 | ACA GENTAMICIN TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1985-08-02 |
| K850060 | DU PONT GENTAMICIN ASSAY REAGENTS | E.I. Dupont DE Nemours & Co., Inc. | 1985-01-18 |
| K832445 | STRATUS GENTAMICIN FLUOROMETRIC ENZYM | American Dade | 1983-08-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740193645 | ARCHITECT | Abbott GmbH | 2026-04-28 |
| 07613336190807 | CEDIA Gentamicin II (GENTC) | Microgenics Corporation | 2020-06-23 |
| 00884883007123 | GENTC | Microgenics Corporation | 2019-11-20 |
| 00380740135522 | Alinity | ABBOTT LABORATORIES | 2018-12-31 |
| 00630414595979 | Atellica CH Gent | Siemens Healthcare Diagnostics Inc. | 2017-12-21 |
| 00884883001312 | CEDIA Gentamicin II Assay | Microgenics Corporation | 2016-09-24 |
| 00630414561943 | ADVIA® Chemistry GENT_2 Gentamicin_2 Reagents | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414527307 | ADVIA Centaur® Gentamicin MCM | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414527291 | ADVIA Centaur® Systems Gentamicin Calibrator | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414527284 | ADVIA Centaur® Systems, ACS:180® Systems GENT Calibrator | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414527277 | ADVIA Centaur® GENT | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00884883012677 | QMS Gentamicin Assay | Microgenics Corporation | 2016-09-24 |
| 00842768023316 | Emit® 2000 Gentamicin Plus Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015212 | Dimension Vista® Flex® reagent cartridge GENT | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005336 | Dimension® Flex® reagent cartridge GENT | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001093 | Syva® Emit® 2000 Gentamicin Plus Calibrators | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768001086 | Syva® Emit® 2000 Gentamicin Plus Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 05055273206449 | GENT | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 00884883011205 | QMS Gentamycin Immunoassay | Microgenics Corporation | 2016-09-22 |
| 04015630994939 | CEDIA Gentamicin II | Roche Diagnostics GmbH | 2016-09-20 |
| 00380740001735 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 00380740001742 | ARCHITECT | Abbott GmbH | 2016-09-09 |
| 15099590232061 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 10758750006755 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-10 |
| 00380740000301 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |