Definition: CBER
Device Type ID | 2426 |
Device Name | Test, Residual, Wbc In Leukoreduced Blood |
Regulation Description | Hematology Quality Control Mixture. |
Regulation Medical Specialty | Hematology |
Review Panel | Hematology |
Premarket Review | Center For Biologics Evaluation & Research (CBER) |
Submission Type | 510(k) |
CFR Regulation Number | 864.8625 [🔎] |
FDA Device Classification | Class 2 Medical Device |
Product Code | MZG |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 2426 |
Device | Test, Residual, Wbc In Leukoreduced Blood |
Product Code | MZG |
FDA Device Classification | Class 2 Medical Device |
Regulation Description | Hematology Quality Control Mixture. |
CFR Regulation Number | 864.8625 [🔎] |