510(k) K012978
- Device
- RANDOX GENTAMICIN
- Applicant
- RANDOX LABORATORIES, LTD.
- 510(k) number
- K012978
- Product code
- LCD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-09-18
- Date received
- 2001-07-06
- Regulation
- 862.3450
- Classification name
- Enzyme Immunoassay, Gentamicin
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAULINE ARMSTRONG
- Address
- Ardmore, Diamond Rd. Crumlin IE BT29 4QY BT29 4QY
FDA Registration Numbers#
- 3010939897
- 2517506
- 2432235
- 3005333358
- 3006198300
- 3002806944
- 3004493545
- 1319808
- 3000308930
- 3002809144
- 3010825766
- 3002642396
- 8020888
- 3005755244
- 3012963943
- 2250051
- 3033967997
- 2050012
- 3003561301
- 2050010
- 1219913
- 1319681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LCD #
| 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 |
| 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 |
Legacy Summary#
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FDA Review#
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