← Product Code [CIC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC) · K863003 # EMDS(TM) CALCIUM TESTPACKS, #67687/95 (K863003) _Em Diagnostic Systems, Inc. · CIC · Sep 16, 1986 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K863003 ## Device Facts - **Applicant:** Em Diagnostic Systems, Inc. - **Product Code:** [CIC](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC.md) - **Decision Date:** Sep 16, 1986 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1145 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Regulatory Identification A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K863003](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIC/K863003) **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/CIC/K863003