← Product Code [JCF](/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF) · K842146

# HISTOPAQUE-1077 (K842146)

_Sigma Chemical Co. · JCF · Jul 27, 1984 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K842146

## Device Facts

- **Applicant:** Sigma Chemical Co.
- **Product Code:** [JCF](/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF.md)
- **Decision Date:** Jul 27, 1984
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8500
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

A lymphocyte separation medium is a device used to isolate lymphocytes from whole blood.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K842146](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/JCF/K842146)

**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