Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart G — Manual Hematology Devices](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices) → [21 CFR 864.6650](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6650) → JBZ — Study, Platelet Adhesive

# JBZ · Study, Platelet Adhesive

_Hematology · 21 CFR 864.6650 · Class 2_

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

## Overview

- **Product Code:** JBZ
- **Device Name:** Study, Platelet Adhesive
- **Regulation:** [21 CFR 864.6650](/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/864.6650)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)

## Identification

A platelet adhesion test is a device used to determine in vitro platelet function.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (3 of 3)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K800037](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBZ/K800037.md) | PLATELET RETENTION (ADHESION) COLUMNS | Hemometrix | Feb 5, 1980 | SESE |
| [K771678](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBZ/K771678.md) | THROMBO-SCREEN PLATELET ADHESION | Bay Area Hema. Onco. Clinic. & Res. L | Nov 22, 1977 | SESE |
| [K771523](https://fda.innolitics.com/submissions/HE/subpart-g%E2%80%94manual-hematology-devices/JBZ/K771523.md) | LATELET RETENTION COLUMN | Bd Becton Dickinson Vacutainer Systems Preanalytic | Nov 22, 1977 | SESE |

## Top Applicants

- Bay Area Hema. Onco. Clinic. & Res. L — 1 clearance
- Bd Becton Dickinson Vacutainer Systems Preanalytic — 1 clearance
- Hemometrix — 1 clearance

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

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