Radioimmunoassay, Conjugated Sulfalithocholic (Slcg) Acid, Bile Acids
The Conjugated Sulfalithocholic Acid (SLCG) Bile Acids Radioimmunoassay is an in vitro diagnostic device used to quantify sulfalithocholic acid conjugates, a specific class of bile acids, in patient serum to evaluate hepatic function and bile acid metabolism. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KWX, regulated under 21 CFR 862.1187, in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- KWX
- Device Class
- FDA class 2
- Regulation Number
- 862.1187
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.