← Product Code [LCO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO) · K890633

# ENZYGNOST PLATELET FACTOR 4 (PF4) KIT (K890633)

_Behring Diagnostics, Inc. · LCO · Apr 21, 1989 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K890633

## Device Facts

- **Applicant:** Behring Diagnostics, Inc.
- **Product Code:** [LCO](/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO.md)
- **Decision Date:** Apr 21, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.7695
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K890633](https://fda.innolitics.com/submissions/HE/subpart-h%E2%80%94hematology-kits-and-packages/LCO/K890633)

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