Product Code: DKD
FDA class 2
21 CFR 862.3450
Bacillus Subtilis, Microbiological Assay, Gentamicin
Clinical Toxicology
The Bacillus Subtilis Microbiological Assay for Gentamicin is a bioassay method that uses the susceptibility of Bacillus subtilis to gentamicin, an aminoglycoside antibiotic, to quantify gentamicin concentrations in patient specimens for therapeutic drug monitoring. It is classified as FDA Class 2, requiring 510(k) premarket notification, and is regulated under 21 CFR 862.3450 within the Clinical Toxicology specialty. This device qualifies for third-party 510(k) review.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
1
Basic Information
- Product Code
- DKD
- 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 2 510(k) clearances via K numbers.