← Product Code [GGJ](/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGJ) · K926422

# VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY (K926422)

_Syva Co. · GGJ · Jun 2, 1993 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGJ/K926422

## Device Facts

- **Applicant:** Syva Co.
- **Product Code:** [GGJ](/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGJ.md)
- **Decision Date:** Jun 2, 1993
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8200
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.

---

**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGJ/K926422](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/GGJ/K926422)

**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
