FDA 510(k)

MDx-Chex for BCID2

Número K: K212576 · 2022-01-19

Data da decisão2022-01-19

Código do produtoPMN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

MDx-Chex for BCID2 is the device name listed in this FDA 510(k) record. The listed applicant is Streck, Inc.. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K212576. The device is classified under product code PMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the MDx-Chex for BCID2?

MDx-Chex for BCID2 is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Streck, Inc.. The 510(k) number is K212576.

When did MDx-Chex for BCID2 receive FDA 510(k) clearance?

MDx-Chex for BCID2 received FDA 510(k) clearance on 2022-01-19, under 510(k) number K212576.

Who is the listed applicant for MDx-Chex for BCID2?

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 MDx-Chex for BCID2?

The FDA product code for MDx-Chex for BCID2 is PMN.

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.

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Fonte oficial

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