Porter Silber Hydrazone, 17-Hydroxycorticosteroids
The Porter-Silber Hydrazone 17-Hydroxycorticosteroids Test is a clinical chemistry device that uses the Porter-Silber colorimetric reaction to quantify 17-hydroxycorticosteroid levels in urine, providing a measure of cortisol and related glucocorticoid metabolites as an indicator of adrenocortical function. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CDB, regulated under 21 CFR 862.1385, within the Clinical Chemistry medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CDB
- Device Class
- FDA class 1
- Regulation Number
- 862.1385
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.