# AMICUS Apheresis Kits AMICUS Separator System (BK120082)

_Fenwal Inc · Jan 8, 2013 · SESE_

**Canonical URL:** https://fda.innolitics.com/device/BK120082

## Device Facts

- **Applicant:** Fenwal Inc
- **Decision Date:** Jan 8, 2013
- **Decision:** SESE

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**Source:** [https://fda.innolitics.com/device/BK120082](https://fda.innolitics.com/device/BK120082)

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