| Device Type ID | 2410 |
| Device Name | Platelet Factor 4 Radioimmunoassay |
| Regulation Description | Platelet Factor 4 Radioimmunoassay. |
| 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 | 864.7695 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LCO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2410 |
| Device | Platelet Factor 4 Radioimmunoassay |
| Product Code | LCO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Platelet Factor 4 Radioimmunoassay. |
| CFR Regulation Number | 864.7695 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
INSTRUMENTATION LABORATORY | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
INSTRUMENTATION LABORATORY CO. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
False Reading From Device Non-Compliance | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Genetic Testing Institute,inc | II | Jan-20-2015 |
| 2 | Hyphen BioMed | II | May-08-2018 |
| 3 | Hyphen BioMed | II | Mar-15-2018 |