← Product Code [JRQ](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRQ) · K813148

# S/P VORTEX MIXER (K813148)

_American Dade · JRQ · Nov 24, 1981 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRQ/K813148

## Device Facts

- **Applicant:** American Dade
- **Product Code:** [JRQ](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRQ.md)
- **Decision Date:** Nov 24, 1981
- **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.

---

**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRQ/K813148](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRQ/K813148)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com