← Product Code [KSP](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSP) · K881465

# CRYOBIOLOGICAL FREEZER (K881465)

_Cryodyne Technologies, Inc. · KSP · Apr 21, 1988 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/PA/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSP/K881465

## Device Facts

- **Applicant:** Cryodyne Technologies, Inc.
- **Product Code:** [KSP](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSP.md)
- **Decision Date:** Apr 21, 1988
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.9225
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory Identification

Cell-freezing apparatus and reagents for in vitro diagnostic use are devices used to freeze human red blood cells for in vitro diagnostic use.

---

**Source:** [https://fda.innolitics.com/submissions/PA/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSP/K881465](https://fda.innolitics.com/submissions/PA/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSP/K881465)

**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