Enzymatic Radiochemical Assay, Tobramycin
Enzymatic radiochemical assay for tobramycin is a laboratory method combining enzymatic and radiochemical techniques to quantify tobramycin serum concentrations in patients undergoing aminoglycoside antibiotic therapy, where monitoring is critical to maintain efficacy and prevent nephrotoxicity and ototoxicity. FDA Class 2 classification applies, requiring 510(k) premarket notification. The product code is LDO, regulated under 21 CFR 862.3900, in the Clinical Toxicology specialty. Third-party review is available.
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Basic Information
- Product Code
- LDO
- Device Class
- FDA class 2
- Regulation Number
- 862.3900
- Medical Specialty
- Clinical Toxicology
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
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 |
|---|---|---|---|---|
| K043384 | VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III | Feb 07, 2005 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K841556 | HEART - AID ALS, 95 | Jul 19, 1984 | Substantially Equivalent | Cardiac Resucitator Corp. |
| K832055 | EMIT ASSAY AND TOBRAMYCIN | Aug 08, 1983 | Substantially Equivalent | Syva Co. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.