API TURBICITY STANDARD
Device Facts
| Record ID | K810762 |
|---|---|
| Device Name | API TURBICITY STANDARD |
| Applicant | Analytical Products, Inc. |
| Product Code | JKP · Clinical Chemistry |
| Decision Date | Apr 3, 1981 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1130 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A blood volume test system is a device intended to measure the circulating blood volume. Blood volume measurements are used in the diagnosis and treatment of shock, hemorrhage, and polycythemia vera (a disease characterized by an absolute increase in erythrocyte mass and total blood volume).
