| Device Type ID | 2391 |
| Device Name | Kit, Quality Control For Blood Banking Reagents |
| Regulation Description | Quality Control Kit For Blood Banking Reagents. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.9650 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | KSF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2391 |
| Device | Kit, Quality Control For Blood Banking Reagents |
| Product Code | KSF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Quality Control Kit For Blood Banking Reagents. |
| CFR Regulation Number | 864.9650 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIO-RAD MEDICAL DIAGNOSTICS GMBH | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
MEDION GRIFOLS DIAGNOSTICS AG | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MICRO TYPING SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRO TYPING SYSTEMS INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
False Negative Result | 20 |
Human Factors Issue | 1 |
| Total Device Problems | 21 |