Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests)
FDA 510(k) K012311 · Diagnostic Products Corp.
510(k) numberK012311
Submission
- Device name
- Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests)
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- July 23, 2001
- Decision date
- August 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCD – Enzyme Immunoassay, Gentamicin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3450
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LCD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243500 | ARCHITECT iGentamicinLCD · Special | Abbott Laboratories | 07/09/2025SE |
| K102699 | Architect Igentamicin Reagents; Architect Igentamicin CalibratorsLCD · Traditional | Abbott Laboratories | 04/01/2011SE |
| K060709 | Multigent GentamicinLCD · Traditional | Seradyn, Inc. | 06/15/2006SE |
| K042479 | Vitros Chemistry Products Gent, Tobra & Vanc Reagents; Vitros Chemistyr Products…LCD · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/06/2005SE |
| K020704 | Roche Online GentamicinLCD · Traditional | Roche Diagnostics Corp. | 07/12/2002SE |
| K012978 | Randox GentamicinLCD · Traditional | Randox Laboratories, Ltd. | 09/18/2001SE |
| K010984 | Emit 2000 Gentamicin Plus AssayLCD · Special | Syva Co., Dade Behring, Inc. | 04/20/2001SE |
| K962819 | Gentamicin Flex Reagent CartridgeLCD · Traditional | Dade Intl., Inc. | 09/13/1996SE |
| K962519 | Emit 2000 Gentamicin Assay and CalibratorsLCD · Traditional | Behring Diagnostics, Inc. | 09/04/1996SE |
| K953020 | Acs GentamicinLCD · Traditional | Ciba Corning Diagnostics Corp. | 08/02/1995SE |
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|---|---|---|
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| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests) cleared by the FDA?
Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests) (K012311) received a 510(k) decision of Substantially Equivalent on August 20, 2001, 28 days after the submission was received.
What is the product code of K012311?
The FDA product code is LCD – Enzyme Immunoassay, Gentamicin, a Class II (moderate risk) device regulated under 21 CFR 862.3450.