FDA 510(k)

Cell-Free DNA BCT

Número K: K231776 · 2024-07-26

Data da decisão2024-07-26

Código do produtoQMA

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Cell-Free DNA BCT is the device name listed in this FDA 510(k) record. The listed applicant is Streck, Inc.. It received FDA 510(k) clearance on 2024-07-26 under 510(k) number K231776. The device is classified under product code QMA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Cell-Free DNA BCT?

Cell-Free DNA BCT is a medical device that received FDA 510(k) clearance on 2024-07-26. The listed applicant is Streck, Inc.. The 510(k) number is K231776.

When did Cell-Free DNA BCT receive FDA 510(k) clearance?

Cell-Free DNA BCT received FDA 510(k) clearance on 2024-07-26, under 510(k) number K231776.

Who is the listed applicant for Cell-Free DNA BCT?

The FDA 510(k) record lists Streck, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Cell-Free DNA BCT?

The FDA product code for Cell-Free DNA BCT is QMA.

Outros registros que listam Streck, Inc. 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.

K212576MDx-Chex for BCID2

Fonte oficial

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