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) → JBX — Aggregrometer, Platelet

# JBX · Aggregrometer, Platelet

_Hematology · 21 CFR 864.6675 · Class 2_

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

## Overview

- **Product Code:** JBX
- **Device Name:** Aggregrometer, Platelet
- **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 (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K932566](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K932566.md) | AGGRO/LINK CONTROL SOFTWARE | Chrono-Log Corp. | Nov 2, 1993 | SESE |
| [K912774](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K912774.md) | ARACHIDONIC ACID | Helena Laboratories | Aug 22, 1991 | SESE |
| [K881829](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K881829.md) | PAT PLATELET AGGREGATION TEST | Streck Laboratories, Inc. | Jul 1, 1988 | SESE |
| [K862775](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K862775.md) | ASSERACHROM B-TG KIT | American Bioproducts Co. | Oct 22, 1986 | SESE |
| [K851025](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K851025.md) | AGGRO/LINK COMPUTER INTERFACE | Chrono-Log Corp. | Jun 12, 1985 | SESE |
| [K850592](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K850592.md) | PLATELET AGGREGATION REAGENT | Chrono-Log Corp. | May 13, 1985 | SESE |
| [K832929](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K832929.md) | RISTOCETIN PLATELET AGGREGA-REAGENT TEST | Sigma Chemical Co. | Sep 29, 1983 | SESE |
| [K830749](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K830749.md) | PLATELET AGGREGOMETER | Chrono-Log Corp. | May 16, 1983 | SESE |
| [K821005](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K821005.md) | PLATELET AGGREGATION PROFILER #PAP-4 | Bio/Data Corp. | Jun 1, 1982 | SESE |
| [K811290](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K811290.md) | ARACHIDONIC ACID | Bio/Data Corp. | Jul 27, 1981 | SESE |
| [K781710](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K781710.md) | BUFFER, COLLAGEN REAGENT AND DILUENT | Diagnostica, Inc. | Oct 24, 1978 | SESE |
| [K760159](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBX/K760159.md) | AGGREGOMETER, DUAL CHANNEL PLATELET | Chrono-Log Corp. | Jul 20, 1976 | SESE |

## Top Applicants

- Chrono-Log Corp. — 5 clearances
- Bio/Data Corp. — 2 clearances
- American Bioproducts Co. — 1 clearance
- Diagnostica, Inc. — 1 clearance
- Helena Laboratories — 1 clearance

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

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