← Product Code [DDR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR) · K915850

# OPUS MYOGLOBIN TEST SYSTEM (K915850)

_Pb Diagnostic Systems, Inc. · DDR · Mar 17, 1992 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR/K915850

## Device Facts

- **Applicant:** Pb Diagnostic Systems, Inc.
- **Product Code:** [DDR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR.md)
- **Decision Date:** Mar 17, 1992
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5680
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Regulatory Identification

A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

---

**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR/K915850](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR/K915850)

**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