LCD — Enzyme Immunoassay, Gentamicin Class II
FDA product code LCD covers "Enzyme Immunoassay, Gentamicin", a Class II medical device regulated under 21 CFR 862.3450. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |