SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS— 510(k) K172197

Substantially Equivalent

Origio A/S

FDA 510(k) clearance K172197 for SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS, Substantially Equivalent on 2017-10-13. Applicant: Origio A/S.

Clearance details

Applicant: Origio A/S
Product code: Code MQL
Advisory panel: Obstetrics/Gynecology
Date received: 2017-07-21
Decision date: 2017-10-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Måløv, DK

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