← Product Code [DDX](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX) · K781478

# PLASMINOGEN ASSAY (K781478)

_Dade, Baxter Travenol Diagnostics, Inc. · DDX · Nov 15, 1978 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K781478

## Device Facts

- **Applicant:** Dade, Baxter Travenol Diagnostics, Inc.
- **Product Code:** [DDX](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX.md)
- **Decision Date:** Nov 15, 1978
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5715
- **Device Class:** Class 1
- **Review Panel:** Immunology

## Regulatory Identification

A plasminogen immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the plasminogen (an inactive substance from which plasmin, a blood-clotting factor, is formed) in serum, other body fluids, and tissues. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K781478](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDX/K781478)

**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