Device Type ID | 3016 |
Device Name | Plates And Equipment, Radial Immunodiffusion |
Regulation Description | Radial Immunodiffusion Plate. |
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 | 866.4800 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | JZQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 3016 |
Device | Plates And Equipment, Radial Immunodiffusion |
Product Code | JZQ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Radial Immunodiffusion Plate. |
CFR Regulation Number | 866.4800 [🔎] |
Recalls | |||
---|---|---|---|
Manufacturer | Recall Class | Date Posted | |
1 | The Binding Site Group, Ltd. | II | Jan-19-2017 |