K243500
- 510(k) number
- K243500
- Device name
- ARCHITECT iGentamicin
- Applicant
- Abbott Laboratories IL · US
- Product code
- LCD — Enzyme Immunoassay, Gentamicin
- Decision date
- 2025-07-09
- Date received
- 2024-11-12
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Toxicology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243500.pdf
Official FDA record: K243500
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.