← Product Code [JQC](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQC) · K850485

# ROTOR SYSTEMS A/S-400 & LA/S-400 (K850485)

_E.I. Dupont DE Nemours & Co., Inc. · JQC · Mar 12, 1985 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQC/K850485

## Device Facts

- **Applicant:** E.I. Dupont DE Nemours & Co., Inc.
- **Product Code:** [JQC](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQC.md)
- **Decision Date:** Mar 12, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2050
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Regulatory Identification

General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQC/K850485](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQC/K850485)

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