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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 the device name listed in this FDA 510(k) record. The listed applicant is Origio A/S. It received FDA 510(k) clearance on 2017-10-13 under 510(k) 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. The listed applicant is Origio A/S. The 510(k) number is K172197.

When did SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS receive FDA 510(k) clearance?

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

Who is the listed applicant for SAGE 1-Step GM-CSF with HSA, SAGE 1-Step GM-CSF with SPS?

The FDA 510(k) record lists Origio A/S as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Origio A/S as applicant

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Related Devices (Code: MQL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato CorporationK242640FertiCult Flushing medium; FertiCult Flushing medium with phenol red and gentamicinFertipro NV

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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