← Product Code [DDR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR) · K000196

# ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 (K000196)

_Beckman Coulter, Inc. · DDR · Feb 18, 2000 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DDR/K000196

## Device Facts

- **Applicant:** Beckman Coulter, Inc.
- **Product Code:** [DDR](/submissions/IM/subpart-f%E2%80%94immunological-test-systems/DDR.md)
- **Decision Date:** Feb 18, 2000
- **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/CH/subpart-f%E2%80%94immunological-test-systems/DDR/K000196](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94immunological-test-systems/DDR/K000196)

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