Product Code: LCE
FDA class 2
21 CFR 862.3450
Radioimmunoassay, Netilmicin (I-125)
Clinical Toxicology
Radioimmunoassay for netilmicin using iodine-125 tracer is a laboratory test method used in clinical toxicology to measure serum levels of netilmicin, an aminoglycoside antibiotic that requires therapeutic drug monitoring to minimize the risk of toxicity. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is LCE, regulated under 21 CFR 862.3450, in the Clinical Toxicology specialty. No special risk flags apply.
510(k)s
6
FEI Numbers
0
Registration Numbers
0
Unique Applicants
5
Years Active
2
Research product code LCE in seconds
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Basic Information
- Product Code
- LCE
- Device Class
- FDA class 2
- Regulation Number
- 862.3450
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K833715 | EMIT NETILMICIN ASSAY | Dec 27, 1983 | Substantially Equivalent | Syva Co. |
| K832088 | AMES TDA NETILMICIN TEST & SERUM | Oct 28, 1983 | Substantially Equivalent | Miles Laboratories, Inc. |
| K822941 | NETILMICIN FLUORESCENT IMMUNOASSAY | Oct 26, 1982 | Substantially Equivalent | American Diagnostic Corp. |
| K821698 | TDX NETILMICIN | Jun 22, 1982 | Substantially Equivalent | Abbott Laboratories |
| K821399 | MACRO-VUE CARD TEST, NETILMICIN | May 28, 1982 | Substantially Equivalent | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| K820324 | EMIT AND NETILMICIN ASSAY | Feb 23, 1982 | Substantially Equivalent | Syva Co. |