Immunodiffusion, Protein Fractionation
The Immunodiffusion, Protein Fractionation device is a clinical chemistry diagnostic system that uses immunodiffusion techniques to separate and identify protein fractions in serum or other biological specimens, supporting the detection and characterization of immunoglobulin abnormalities and protein disorders through antibody-antigen precipitation reactions. This device is FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. It carries product code JQK and is regulated under 21 CFR 862.1630, within the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- JQK
- Device Class
- FDA class 1
- Regulation Number
- 862.1630
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K781898 | CLEARING SOLUTION #ECA01976 | Dec 20, 1978 | Substantially Equivalent | Electrophoresis Corp. of America |