Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2920](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2920) → JJL — Plasma Viscometer For Clinical Use

# JJL · Plasma Viscometer For Clinical Use

_Clinical Chemistry · 21 CFR 862.2920 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJL

## Overview

- **Product Code:** JJL
- **Device Name:** Plasma Viscometer For Clinical Use
- **Regulation:** [21 CFR 862.2920](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2920)
- **Device Class:** 1
- **Review Panel:** [Clinical Chemistry](/submissions/CH)

## 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](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJL/K883503.md) | COULTER VISCOMETER II | Coulter Electronics, Inc. | Sep 19, 1988 | SESE |

## Top Applicants

- Coulter Electronics, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJL](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJL)

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