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Substantially Equivalent 510(k) Device Information
BK261329- Erytra Eflexis

Substantially Equivalent 510(k) Device Information

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Substantially Equivalent 510(k) Device Information

BK261329- Erytra Eflexis

Substantially Equivalent 510(k) Device Information

510(k) Number: BK261329
Applicant: Diagnostic Grifols S.A.
Device Name: Erytra Eflexis
Decision Date: 05/21/2026

Supporting Documents

BK261329 Letter
BK261329 Summary

Content current as of:

05/28/2026
Regulated Product(s)
- Biologics

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