← Product Code [DDR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR) · K922125

# STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY (K922125)

_Baxter Diagnostics, Inc. · DDR · Jul 21, 1992 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR/K922125

## Device Facts

- **Applicant:** Baxter Diagnostics, Inc.
- **Product Code:** [DDR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR.md)
- **Decision Date:** Jul 21, 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.

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**Source:** [https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR/K922125](https://fda.innolitics.com/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR/K922125)

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