FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARCHITECT iGentamicin
K Number: K243500
·
Decision Jul 9, 2025
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
36
Applicant Total
883
Review Days
239
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Basic Information
- Device Name
- ARCHITECT iGentamicin
- K Number
- K243500
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3450
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Laboratories
- Date Received
- November 12, 2024
- Decision Date
- July 9, 2025
- Product Code
- LCD
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LCD | Enzyme Immunoassay, Gentamicin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
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