# Erytra Eflexis (BK200467)

_Diagnostic Grifols, S. A. · Apr 23, 2020 · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/BK200467

## Device Facts

- **Applicant:** Diagnostic Grifols, S. A.
- **Decision Date:** Apr 23, 2020
- **Decision:** SESE

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**Source:** [https://fda-staging.innolitics.com/device/BK200467](https://fda-staging.innolitics.com/device/BK200467)

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