Definition: For Total Protein Testing Of Plasma Donors To Determine Eligibility.
| Device Type ID | 673 |
| Device Name | Refractometer For Donor Testing |
| Physical State | Standalone Device |
| Technical Method | Refraction Index To Determine Total Protein Concentration |
| Target Area | Testing Of Plasma |
| Regulation Description | Refractometer For Clinical Use. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.2800 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | PSM |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 673 |
| Device | Refractometer For Donor Testing |
| Product Code | PSM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Refractometer For Clinical Use. |
| CFR Regulation Number | 862.2800 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
REICHERT INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |