← Product Code [JJS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJS) · K901976 # BLOOD GAS/CO-OXIMETRY CONTROL (K901976) _Phoenix Diagnostics, Inc. · JJS · May 31, 1990 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJS/K901976 ## Device Facts - **Applicant:** Phoenix Diagnostics, Inc. - **Product Code:** [JJS](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJS.md) - **Decision Date:** May 31, 1990 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1660 - **Device Class:** Class 1 - **Review Panel:** Clinical Chemistry ## Regulatory Identification A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls. --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJS/K901976](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JJS/K901976) **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-b%E2%80%94clinical-chemistry-test-systems/JJS/K901976