FDA 510(k)

PAXgene® Blood DNA Tube

Número K: K231469 · 2023-06-21

Data da decisão2023-06-21

Código do produtoPJE

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

PAXgene® Blood DNA Tube is the device name listed in this FDA 510(k) record. The listed applicant is Preanalytix GmbH. It received FDA 510(k) clearance on 2023-06-21 under 510(k) number K231469. The device is classified under product code PJE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the PAXgene® Blood DNA Tube?

PAXgene® Blood DNA Tube is a medical device that received FDA 510(k) clearance on 2023-06-21. The listed applicant is Preanalytix GmbH. The 510(k) number is K231469.

When did PAXgene® Blood DNA Tube receive FDA 510(k) clearance?

PAXgene® Blood DNA Tube received FDA 510(k) clearance on 2023-06-21, under 510(k) number K231469.

Who is the listed applicant for PAXgene® Blood DNA Tube?

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

What is the FDA product code for PAXgene® Blood DNA Tube?

The FDA product code for PAXgene® Blood DNA Tube is PJE.

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