| Device Type ID | 2316 |
| Device Name | System, Hemoglobin, Automated |
| Regulation Description | Automated Hemoglobin System. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.5620 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GKR |
| 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 | 2316 |
| Device | System, Hemoglobin, Automated |
| Product Code | GKR |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Automated Hemoglobin System. |
| CFR Regulation Number | 864.5620 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EKF-DIAGNOSTIC GMBH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IMMUNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
RADIOMETER MEDICAL APS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 5 |
Computer Software Problem | 4 |
High Test Results | 3 |
Low Test Results | 2 |
Device Issue | 1 |
Device Handling Problem | 1 |
Incorrect Or Inadequate Test Results | 1 |
Output Problem | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 19 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc. | II | Aug-24-2018 |
| 2 | Stanbio Laboratory, LP | II | Aug-24-2018 |