FDA 510(k)

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

Número K: K172197 · 2017-10-13

Data da decisão2017-10-13

Código do produtoMQL

Comité consultivoOB

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

Outros registros que listam Origio A/S como candidato(a)

Registros relacionados são pareados automaticamente usando nomes, códigos de produtos ou outros metadados. Um pareamento não estabelece um vínculo clínico, científico, corporativo ou regulatório verificado; revise as fontes oficiais vinculadas.

K200815VitriGuard K180740VitriGuard K173624ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)K161547Transem and EchoGen Embryo Transfer Catheters K162833VitriGuard K153267ORIGIO Gradient 100, ORIGIO Gradient 90, ORIGIO Gradient 40/80, ORIGIO Sperm Wash

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