| Device Type ID | 2303 |
| Device Name | Abnormal Hemoglobin Quantitation |
| Regulation Description | Abnormal Hemoglobin Assay. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 864.7415 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GKA |
| 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 | 2303 |
| Device | Abnormal Hemoglobin Quantitation |
| Product Code | GKA |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Abnormal Hemoglobin Assay. |
| CFR Regulation Number | 864.7415 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIO-RAD LABORATORIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEBIA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Clark Laboratories, Inc. (dba,Trinity Biotech USA) | II | Dec-18-2018 |