Electrophoresis Instrumentation
Electrophoresis Instrumentation is a laboratory instrument system used to separate proteins, nucleic acids, or other charged molecules in biological specimens by applying an electric field across a support medium, enabling characterization of serum proteins, immunoglobulins, and other analytes in immunological and clinical laboratory testing. It is classified as FDA Class 1, the lowest risk category, subject to general controls only. The product code is JZS, regulated under 21 CFR 866.4500, and falls within the Immunology medical specialty.
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Basic Information
- Product Code
- JZS
- Device Class
- FDA class 1
- Regulation Number
- 866.4500
- Medical Specialty
- Immunology
- Review Panel
- IM
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K933123 | SYNELISA TG ANTIBODIES/TPO ANTIBODIES | Aug 23, 1993 | Substantially Equivalent | Elias U.S.A., Inc. |
| K812194 | IMMUNODIFFUSION BAND INTENSIFYING FLUID | Aug 31, 1981 | Substantially Equivalent | American Scientific Products |
| K770566 | IMMUNOELECTROPHORESIS PROFILE KIT | Apr 27, 1977 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K770719 | IMMUNOELECTROFILM KIH | Apr 26, 1977 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K770718 | STAIN, R-250, COOMASSIE BRILLIANT BLUE | Apr 26, 1977 | Substantially Equivalent | Kallestad Laboratories, Inc. |
| K770150 | ELECTRO IMMUNO ASSAY KIT | Feb 01, 1977 | Substantially Equivalent | Millipore Corp. |