← Product Code [JJL](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJL) · K883503

# COULTER VISCOMETER II (K883503)

_Coulter Electronics, Inc. · JJL · Sep 19, 1988 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJL/K883503

## Device Facts

- **Applicant:** Coulter Electronics, Inc.
- **Product Code:** [JJL](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJL.md)
- **Decision Date:** Sep 19, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2920
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJL/K883503](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJL/K883503)

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