FDA Product Code
FDA Product Code LCD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Toxicology
- 21 CFR Citation
- 862.3450
510(k) Clearances — 37 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K243500 | ARCHITECT iGentamicin | Abbott Laboratories | 2025-07-09 | Special | PDF ↗ |
| K102699 | ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS | Abbott Laboratories | 2011-04-01 | Traditional | PDF ↗ |
| K060709 | MULTIGENT GENTAMICIN | Seradyn, Inc. | 2006-06-15 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K020704 | ROCHE ONLINE GENTAMICIN | Roche Diagnostics Corp. | 2002-07-12 | Traditional | PDF ↗ |
| K012978 | RANDOX GENTAMICIN | Randox Laboratories, Ltd. | 2001-09-18 | Traditional | PDF ↗ |
| K012311 | IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) | Diagnostic Products Corp. | 2001-08-20 | Traditional | PDF ↗ |
| K010984 | EMIT 2000 GENTAMICIN PLUS ASSAY | Syva Co., Dade Behring, Inc. | 2001-04-20 | Special | PDF ↗ |
| K962819 | GENTAMICIN FLEX REAGENT CARTRIDGE | Dade Intl., Inc. | 1996-09-13 | Traditional | PDF ↗ |
| K962519 | EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS | Behring Diagnostics, Inc. | 1996-09-04 | Traditional | PDF ↗ |
| K953020 | ACS GENTAMICIN | Ciba Corning Diagnostics Corp. | 1995-08-02 | Traditional | PDF ↗ |
| K943982 | IL TEST GENTAMICIN CALIBRATORS | Instrumentation Laboratory CO | 1995-01-25 | Traditional | PDF ↗ |
| K935376 | AXSYM GENTAMICIN | Abbott Mfg., Inc. | 1994-06-21 | Traditional | PDF ↗ |
| K940376 | QMS GENTAMICIN ASSAY | Seradyn, Inc. | 1994-06-02 | Traditional | PDF ↗ |
| K913470 | CEDIA(R) GENTAMICIN ASSAY | Microgenics Corp. | 1991-09-27 | Traditional | PDF ↗ |
| K904305 | DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1990-10-15 | Traditional | PDF ↗ |
| K903743 | IL GENTAMICIN ASSAY SYSTEM | Instrumentation Laboratory CO | 1990-09-17 | Traditional | PDF ↗ |
| K900703 | MODIFIED ACCUFLUOR GENTAMICIN REAGENT & CALIBRATOR | Innotron of Oregon, Inc. | 1990-04-12 | Traditional | PDF ↗ |
| K895484 | STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. | Baxter Healthcare Corp | 1989-10-04 | Traditional | PDF ↗ |
| K893912 | TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD | Technicon Instruments Corp. | 1989-08-21 | Traditional | PDF ↗ |
| K874703 | EMIT CONVENIENCE PACK: GENTAMICIN ASSAY | Syva Co. | 1987-12-18 | Traditional | PDF ↗ |
| K873855 | EMIT QST GENTAMICIN ASSAY | Syva Co. | 1987-10-29 | Traditional | PDF ↗ |
| K873854 | EMIT GENTAMICIN ASSAY | Syva Co. | 1987-10-28 | Traditional | PDF ↗ |
| K871329 | EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640 | Em Diagnostic Systems, Inc. | 1987-05-12 | Traditional | PDF ↗ |
| K862260 | EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS | Syva Co. | 1986-11-03 | Traditional | PDF ↗ |
| K860868 | TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN | Technicon Instruments Corp. | 1986-04-03 | Traditional | PDF ↗ |
| K860045 | DETERMINATION OF GENTAMICIN | Clinical Data, Inc. | 1986-01-22 | Traditional | PDF ↗ |
| K852672 | ACA GENTAMICIN TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1985-08-02 | Traditional | PDF ↗ |
| K850060 | DU PONT GENTAMICIN ASSAY REAGENTS | E.I. Dupont DE Nemours & Co., Inc. | 1985-01-18 | Traditional | PDF ↗ |
| K832445 | STRATUS GENTAMICIN FLUOROMETRIC ENZYM | American Dade | 1983-08-31 | Traditional | PDF ↗ |
| K832056 | EMIT AMD GENTAMICIN ASSAY | Syva Co. | 1983-08-08 | Traditional | PDF ↗ |
| K831416 | EMIT QST TOBRAMYCIN ASSAY | Syva Co. | 1983-06-08 | Traditional | PDF ↗ |
| K831304 | EMIT QST GENTAMICIN ASSAY | Syva Co. | 1983-06-02 | Traditional | PDF ↗ |
| K823387 | SOPHEIA GENTAMICIN EIA KIT | Diagnostic Products Corp. | 1982-12-22 | Traditional | PDF ↗ |
| K811692 | GENTAMICIN REAGENT TEST KIT | Beckman Instruments, Inc. | 1981-07-15 | Traditional | PDF ↗ |
| K811744 | VIRGO IPA FOR DETECTION OF GENTAMICIN | Electro-Nucleonics Laboratories, Inc. | 1981-07-10 | Traditional | PDF ↗ |
| K800150 | EMIT TOBRAMYCIN ASSAY | Syva Co. | 1980-02-05 | Traditional | PDF ↗ |
Product code LCD · Class II · Clinical Toxicology. Data: openFDA.