← Product Code [JOZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ) · K002885

# DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP (K002885)

_Dade Behring, Inc. · JOZ · Jun 21, 2001 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K002885

## Device Facts

- **Applicant:** Dade Behring, Inc.
- **Product Code:** [JOZ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ.md)
- **Decision Date:** Jun 21, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5700
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K002885](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JOZ/K002885)

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