Axsym Gentamicin
FDA 510(k) K935376 · Abbott Mfg., Inc.
510(k) numberK935376
Submission
- Device name
- Axsym Gentamicin
- Applicant
- Abbott Mfg., Inc.
Abbott Park, IL, US - Received
- November 8, 1993
- Decision date
- June 21, 1994
- 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 |
| K012311 | Immulite 2000 Gentamicin, Models L2KGE2 (200 Tests), L2KGE6 (600 Tests)LCD · Traditional | Diagnostic Products Corp. | 08/20/2001SE |
| 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 |
More from Behring Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981457 | AlbpCJW · Traditional | 05/27/1998SE |
| K981232 | CaCJY · Traditional | 05/18/1998SE |
| K981231 | CO2KHS · Traditional | 05/12/1998SE |
| K965230 | Abbott Lifecare Standard Tubing Infusion PumpFRN · Traditional | 07/03/1997SE |
| K971293 | Lifeshield Primary I.V. Set with Backcheck ValveFPA · Traditional | 06/27/1997SE |
| K953656 | Abbott Imx Prolactin(Modification)CFT · Traditional | 10/03/1995SE |
| K953657 | Abbott Axsym Prolactin(Modification)CFT · Traditional | 09/25/1995SE |
| K944669 | Flexiflo Quantum Enteral PumpFRN · Traditional | 07/24/1995SE |
| K943691 | Imx FolateCGN · Traditional | 03/23/1995SE |
| K943733 | Flexiflo Six Enteral Nutrition PumpLZH · Traditional | 12/12/1994ST |
Questions and answers
When was Axsym Gentamicin cleared by the FDA?
Axsym Gentamicin (K935376) received a 510(k) decision of Substantially Equivalent on June 21, 1994, 225 days after the submission was received.
What is the product code of K935376?
The FDA product code is LCD – Enzyme Immunoassay, Gentamicin, a Class II (moderate risk) device regulated under 21 CFR 862.3450.