← Product Code [DDR](/productcode/DDR) · K952360

# CARDIAC STATUS, LIFESIGN MI, VITALSIGN, ACCUSIGN CK-MB/MYOGLOBIN (K952360)

_Princeton BioMeditech Corp. · DDR · Aug 14, 1995 · Immunology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K952360

## Device Facts

- **Applicant:** Princeton BioMeditech Corp.
- **Product Code:** [DDR](/productcode/DDR.md)
- **Decision Date:** Aug 14, 1995
- **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/device/K952360](https://fda.innolitics.com/device/K952360)

**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