Device Type ID | 3018 |
Device Name | Electrophoresis Instrumentation |
Regulation Description | Immunoelectrophoresis Equipment. |
Regulation Medical Specialty | Immunology |
Review Panel | Immunology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 866.4500 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | JZS |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3018 |
Device | Electrophoresis Instrumentation |
Product Code | JZS |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Immunoelectrophoresis Equipment. |
CFR Regulation Number | 866.4500 [🔎] |