Device Type ID | 3022 |
Device Name | Fraction V, Antigen, Antiserum, Control |
Regulation Description | Cohn Fraction V Immunological Test System. |
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 | 866.5370 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | KHT |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |