Product Code: LDN
FDA class 2
21 CFR 862.3035
Enzymatic Radiochemical Assay, Amikacin
Clinical Toxicology
Enzymatic radiochemical assay for amikacin is a laboratory test method that combines enzymatic reaction with radiochemical detection to measure serum amikacin levels in patients receiving this aminoglycoside antibiotic, supporting therapeutic drug monitoring to prevent toxicity. It is classified as FDA Class 2, requiring 510(k) premarket clearance. The product code is LDN, regulated under 21 CFR 862.3035, in the Clinical Toxicology specialty. Third-party review eligibility applies.
510(k)s
3
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
2
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Basic Information
- Product Code
- LDN
- Device Class
- FDA class 2
- Regulation Number
- 862.3035
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K840647 | AMIKACIN REAGENT TEST KIT | Apr 02, 1984 | Substantially Equivalent | Beckman Instruments, Inc. |
| K833546 | MODIFICATION OF EMIT AND AMIKACIN ASSAY | Dec 08, 1983 | Substantially Equivalent | Syva Co. |
| K820440 | EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO | Mar 15, 1982 | Substantially Equivalent | Syva Co. |