JJL · Plasma Viscometer For Clinical Use
Clinical Chemistry · 21 CFR 862.2920 · Class 1
Overview
| Product Code | JJL |
|---|---|
| Device Name | Plasma Viscometer For Clinical Use |
| Regulation | 21 CFR 862.2920 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A plasma viscometer for clinical use is a device intended to measure the viscosity of plasma by determining the time period required for the plasma to flow a measured distance through a calibrated glass tube. Measurements obtained by this device are used to monitor changes in the amount of solids present in plasma in various disorders.
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 the limitations in § 862.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K883503 | COULTER VISCOMETER II | Coulter Electronics, Inc. | Sep 19, 1988 | SESE |
Top Applicants
- Coulter Electronics, Inc. — 1 clearance
