K243500 is an FDA 510(k) clearance for the ARCHITECT iGentamicin. This device is classified as a Enzyme Immunoassay, Gentamicin (Class II - Special Controls, product code LCD).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 9, 2025, 239 days after receiving the submission on November 12, 2024.
This device falls under the Toxicology FDA review panel. Regulated under 21 CFR 862.3450.
| 510(k) Number | K243500 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2024 |
| Decision Date | July 09, 2025 |
| Days to Decision | 239 days |
| Submission Type | Special |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
| Product Code | LCD — Enzyme Immunoassay, Gentamicin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.3450 |