← Product Code [JOZ](/productcode/JOZ) · K851669

# MONITOR IV PLUS (K851669)

_Helena Laboratories · JOZ · Jul 23, 1985 · Hematology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K851669

## Device Facts

- **Applicant:** Helena Laboratories
- **Product Code:** [JOZ](/productcode/JOZ.md)
- **Decision Date:** Jul 23, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5700
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.

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**Source:** [https://fda-staging.innolitics.com/device/K851669](https://fda-staging.innolitics.com/device/K851669)

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