IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
FDA 510(k) clearance K012311 · decided 2001-08-20
Clearance details
- K-number
- K012311
- Device name
- IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS)
- Applicant
- Diagnostic Products Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-23
- Decision date
- 2001-08-20
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- LCD
- Device class
- 2
- Regulation number
- 862.3450
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Los Angeles, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Diagnostic Products Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ARCHITECT iGentamicin (K243500) | Abbott Laboratories | 2025-07-09 |
| ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS (K102699) | Abbott Laboratories | 2011-04-01 |
| MULTIGENT GENTAMICIN (K060709) | Seradyn, Inc. | 2006-06-15 |
| VITROS CHEMISTRY PRODUCTS GENT, TOBRA & VANC REAGENTS; VITROS CHEMISTYR PRODUCTS CALIBRATOR KITS 11, 13 & 14; VITROS CHE (K042479) | Ortho-Clinical Diagnostics, Inc. | 2005-01-06 |
| ROCHE ONLINE GENTAMICIN (K020704) | Roche Diagnostics Corp. | 2002-07-12 |
| RANDOX GENTAMICIN (K012978) | Randox Laboratories, Ltd. | 2001-09-18 |
| EMIT 2000 GENTAMICIN PLUS ASSAY (K010984) | Syva Co., Dade Behring, Inc. | 2001-04-20 |
| GENTAMICIN FLEX REAGENT CARTRIDGE (K962819) | Dade Intl., Inc. | 1996-09-13 |
| EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS (K962519) | Behring Diagnostics, Inc. | 1996-09-04 |
| ACS GENTAMICIN (K953020) | Ciba Corning Diagnostics Corp. | 1995-08-02 |
| IL TEST GENTAMICIN CALIBRATORS (K943982) | Instrumentation Laboratory CO | 1995-01-25 |
| AXSYM GENTAMICIN (K935376) | Abbott Mfg., Inc. | 1994-06-21 |
Recalls involving this device
No recalls on record reference this clearance.