Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart F — Automated and Semi-Automated Hematology Devices](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices) → [21 CFR 864.5700](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5700) → OBW — 11-Dehydro Thromboxane B2 Kit, Urinary

# OBW · 11-Dehydro Thromboxane B2 Kit, Urinary

_Hematology · 21 CFR 864.5700 · Class 2_

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

## Overview

- **Product Code:** OBW
- **Device Name:** 11-Dehydro Thromboxane B2 Kit, Urinary
- **Regulation:** [21 CFR 864.5700](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/864.5700)
- **Device Class:** 2
- **Review Panel:** [Hematology](/submissions/HE)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K062025](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/OBW/K062025.md) | ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 | Corgenix, Inc. | May 29, 2007 | SESE |

## Top Applicants

- Corgenix, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/OBW](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/OBW)

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