| Device Type ID | 2307 |
| Device Name | Centrifuge, Hematocrit |
| Regulation Description | Hematocrit Measuring Device. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.6400 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GKG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2307 |
| Device | Centrifuge, Hematocrit |
| Product Code | GKG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hematocrit Measuring Device. |
| CFR Regulation Number | 864.6400 [🔎] |
| Device Problems | |
|---|---|
Device Inoperable | 12 |
Thermal Decomposition Of Device | 5 |
Motor | 4 |
Device Operates Differently Than Expected | 3 |
Melted | 3 |
Smoking | 2 |
Detachment Of Device Component | 2 |
Leak / Splash | 1 |
Loss Of Threshold | 1 |
Power Cord | 1 |
IC (Integrated Circuit) Chip | 1 |
Device Emits Odor | 1 |
Component Falling | 1 |
Loose Or Intermittent Connection | 1 |
Solenoid | 1 |
Optical Fiber | 1 |
Break | 1 |
Charred | 1 |
Mechanical Problem | 1 |
Noise, Audible | 1 |
Gasket | 1 |
Physical Resistance | 1 |
Circuit Board | 1 |
| Total Device Problems | 47 |