← Product Code [DBE](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBE) · K810983

# ANTISMOOTH MUSCLE ANTIBODY TEST SYS (K810983)

_Immuno-Products Industries · DBE · May 1, 1981 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBE/K810983

## Device Facts

- **Applicant:** Immuno-Products Industries
- **Product Code:** [DBE](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBE.md)
- **Decision Date:** May 1, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5120
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

An antismooth muscle antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antismooth muscle antibodies (antibodies to nonstriated, involuntary muscle) in serum. The measurements aid in the diagnosis of chronic hepatitis (inflammation of the liver) and autoimmune connective tissue diseases (diseases resulting from antibodies produced against the body's own tissues).

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBE/K810983](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DBE/K810983)

**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