← Product Code [JJF](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF) · K844586 # IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS (K844586) _Instrumentation Laboratory CO · JJF · Dec 11, 1984 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF/K844586 ## Device Facts - **Applicant:** Instrumentation Laboratory CO - **Product Code:** [JJF](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF.md) - **Decision Date:** Dec 11, 1984 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.2170 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Regulatory Identification A micro chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. The distinguishing characteristic of the device is that it requires only micro volume samples obtainable from pediatric patients. This device is intended for use in conjunction with certain materials to measure a variety of analytes. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF/K844586](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJF/K844586) **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/JJF/K844586