| Device Type ID | 2306 |
| Device Name | Instrument, Hematocrit, Automated |
| Regulation Description | Automated Hematocrit Instrument. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.5600 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GKF |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 2306 |
| Device | Instrument, Hematocrit, Automated |
| Product Code | GKF |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Hematocrit Instrument. |
| CFR Regulation Number | 864.5600 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INSTRUMENTATION LABORATORY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INSTRUMENTATION LABORATORY CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 3 |
Insufficient Information | 1 |
False Positive Result | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 6 |