← Product Code [GIO](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO) · K894851

# TRU-TRAX (K894851)

_Humagen, Inc. · GIO · Sep 29, 1989 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K894851

## Device Facts

- **Applicant:** Humagen, Inc.
- **Product Code:** [GIO](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO.md)
- **Decision Date:** Sep 29, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.6150
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K894851](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GIO/K894851)

**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
