Product Code: DOJ
FDA class 2
21 CFR 862.3040
Potassium Dichromate, Alcohol
Clinical Toxicology
The Potassium Dichromate test for Alcohol is a clinical toxicology assay device that uses the oxidation-reduction reaction between potassium dichromate and ethyl alcohol to detect and measure alcohol concentrations in patient specimens. It is a Class 2 device requiring a 510(k) premarket notification. The product code is DOJ, regulated under 21 CFR 862.3040, within the Clinical Toxicology specialty. It is eligible for third-party 510(k) review.
510(k)s
2
FEI Numbers
0
Registration Numbers
0
Unique Applicants
2
Years Active
11
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Basic Information
- Product Code
- DOJ
- Device Class
- FDA class 2
- Regulation Number
- 862.3040
- 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.