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) → JBY — Aggregometer, Platelet, Photo-Optical Scanning

# JBY · Aggregometer, Platelet, Photo-Optical Scanning

_Hematology · 21 CFR 864.6675 · Class 2_

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

## Overview

- **Product Code:** JBY
- **Device Name:** Aggregometer, Platelet, Photo-Optical Scanning
- **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 (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K912201](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBY/K912201.md) | PACKS-4 (TM) ANALYZER | Helena Laboratories | Aug 16, 1991 | SESE |
| [K771198](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBY/K771198.md) | LUMI-AGGREGOMETER | Chrono-Log Corp. | Aug 2, 1977 | SESE |

## Top Applicants

- Chrono-Log Corp. — 1 clearance
- Helena Laboratories — 1 clearance

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

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