JKP · Chromium-51, Blood Volume
Clinical Chemistry · 21 CFR 862.1130 · Class 1
Overview
| Product Code | JKP |
|---|---|
| Device Name | Chromium-51, Blood Volume |
| Regulation | 21 CFR 862.1130 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K810762 | API TURBICITY STANDARD | Analytical Products, Inc. | Apr 3, 1981 | SESE |
Top Applicants
- Analytical Products, Inc. — 1 clearance
