← Product Code [GHR](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR) · K820422

# PLATELET AGGREGOMETERS (K820422)

_Chrono-Log Corp. · GHR · Mar 16, 1982 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K820422

## Device Facts

- **Applicant:** Chrono-Log Corp.
- **Product Code:** [GHR](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR.md)
- **Decision Date:** Mar 16, 1982
- **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.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K820422](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/GHR/K820422)

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