Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart G — Manual Hematology Devices](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices) → [21 CFR 864.6675](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6675) → GKW — Aggregometer, Platelet, Thrombokinetogram

# GKW · Aggregometer, Platelet, Thrombokinetogram

_Hematology · 21 CFR 864.6675 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GKW

## Overview

- **Product Code:** GKW
- **Device Name:** Aggregometer, Platelet, Thrombokinetogram
- **Regulation:** [21 CFR 864.6675](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6675)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## Identification

A platelet aggregometer 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GKW](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/GKW)

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