ARCHITECT iGentamicin
FDA 510(k) K243500 · Abbott Laboratories
510(k) numberK243500
Submission
- Device name
- ARCHITECT iGentamicin
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- November 12, 2024
- Decision date
- July 9, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|---|
| 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 |
| K953020 | Acs GentamicinLCD · Traditional | Ciba Corning Diagnostics Corp. | 08/02/1995SE |
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Questions and answers
When was ARCHITECT iGentamicin cleared by the FDA?
ARCHITECT iGentamicin (K243500) received a 510(k) decision of Substantially Equivalent on July 9, 2025, 239 days after the submission was received.
What is the product code of K243500?
The FDA product code is LCD – Enzyme Immunoassay, Gentamicin, a Class II (moderate risk) device regulated under 21 CFR 862.3450.