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FDA 510(k)

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS

K-Number: K172197 · 2017-10-13

ApplicantOrigio A/S
Decision Date2017-10-13
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS is a medical device manufactured by Origio A/S. It received FDA 510(k) clearance on 2017-10-13 under approval number K172197. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS?

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS is a medical device that received FDA 510(k) clearance on 2017-10-13. It is manufactured by Origio A/S. The 510(k) number is K172197.

When was SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS approved by the FDA?

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS received FDA 510(k) clearance on 2017-10-13, under approval number K172197.

What company makes SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS?

SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS is manufactured by Origio A/S.

What is the FDA product code for SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS?

The FDA product code for SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS is MQL.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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