LCD — Enzyme Immunoassay, Gentamicin Class II
FDA Device Classification
Classification Details
- Product Code
- LCD
- Device Class
- Class II
- Regulation Number
- 862.3450
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K243500 | abbott laboratories | ARCHITECT iGentamicin | July 9, 2025 |
| K102699 | abbott laboratories | ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS | April 1, 2011 |
| K060709 | seradyn | MULTIGENT GENTAMICIN | June 15, 2006 |
| K042479 | ortho-clinical diagnostics | VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS | January 6, 2005 |
| K020704 | roche diagnostics | ROCHE ONLINE GENTAMICIN | July 12, 2002 |
| K012978 | randox laboratories | RANDOX GENTAMICIN | September 18, 2001 |
| K012311 | diagnostic products | IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) | August 20, 2001 |
| K010984 | syva co., dade behring | EMIT 2000 GENTAMICIN PLUS ASSAY | April 20, 2001 |
| K962819 | dade intl | GENTAMICIN FLEX REAGENT CARTRIDGE | September 13, 1996 |
| K962519 | behring diagnostics | EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS | September 4, 1996 |
| K953020 | ciba corning diagnostics | ACS GENTAMICIN | August 2, 1995 |
| K943982 | instrumentation laboratory | IL TEST GENTAMICIN CALIBRATORS | January 25, 1995 |
| K935376 | abbott mfg | AXSYM GENTAMICIN | June 21, 1994 |
| K940376 | seradyn | QMS GENTAMICIN ASSAY | June 2, 1994 |
| K913470 | microgenics | CEDIA(R) GENTAMICIN ASSAY | September 27, 1991 |
| K904305 | e.i. dupont de nemours and co | DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD | October 15, 1990 |
| K903743 | instrumentation laboratory | IL GENTAMICIN ASSAY SYSTEM | September 17, 1990 |
| K900703 | innotron of oregon | MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR | April 12, 1990 |
| K895484 | baxter healthcare | STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. | October 4, 1989 |
| K893912 | technicon instruments | TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD | August 21, 1989 |