Product code KQI
- Device name
- Assay, Fetal Hemoglobin
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.7455
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
Related GUDID Devices#
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|---|---|---|---|
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| 05700699441348 | Crea Calibration Solution 2 | Radiometer Medical ApS | 2016-09-01 |
| 05700699441294 | Calibration Solution 2 | Radiometer Medical ApS | 2016-09-01 |
| 05700699441287 | Calibration Solution 1 | Radiometer Medical ApS | 2016-09-01 |
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| 05700699441355 | Crea Calibration Solution 1 | Radiometer Medical ApS | 2016-09-01 |
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| 05700699420657 | Membrane for E7066 electrode | Radiometer Medical ApS | 2016-09-01 |
| 05700699420640 | Membrane for E799 electrode | Radiometer Medical ApS | 2016-09-01 |
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