← Product Code [JRQ](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRQ) · K813149 # S/P VORTEX MIXER JR. (K813149) _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/K813149 ## 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/K813149](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRQ/K813149) **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 as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JRQ/K813149