← Product Code [DEX](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX) · K791341

# HUMAN ALPHA, ACID GLYCOPROTEIN (K791341)

_Beckman Instruments, Inc. · DEX · Aug 16, 1979 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX/K791341

## Device Facts

- **Applicant:** Beckman Instruments, Inc.
- **Product Code:** [DEX](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX.md)
- **Decision Date:** Aug 16, 1979
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5420
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

An alpha-1-glycoproteins immunological test system is a device that consists of the reagents used to measure by immunochemical techniques alpha-1-glycoproteins (a group of plasma proteins found in the alpha-1 group when subjected to electrophoresis) in serum and other body fluids. Measurement of specific alpha-1-glycoproteins may aid in the diagnosis of collagen (connective tissue) disorders, tuberculosis, infections, extensive malignancy, and diabetes.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX/K791341](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DEX/K791341)

**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