| Device Type ID | 2407 |
| Device Name | Boxes, View, Blood Grouping |
| Regulation Description | Blood Grouping View Box. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.9185 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KSY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2407 |
| Device | Boxes, View, Blood Grouping |
| Product Code | KSY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Blood Grouping View Box. |
| CFR Regulation Number | 864.9185 [🔎] |
| Device Problems | |
|---|---|
Insufficient Information | 1 |
| Total Device Problems | 1 |