FDA 510(k)

Amplichek I, Negativo , Amplichek I, Nível 1, Amplichek I, Nível 2, Amplichek I, Nível 3, Amplichek I, MiniPak

Número K: K152679 · 2016-05-10

Data da decisão2016-05-10

Código do produtoPMN

Comité consultivoMI

DecisãoSubstantially Equivalent

Resumo do dispositivo

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad Laboratories. It received FDA 510(k) clearance on 2016-05-10 under 510(k) number K152679. 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 Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak?

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak is a medical device that received FDA 510(k) clearance on 2016-05-10. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K152679.

When did Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak receive FDA 510(k) clearance?

Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak received FDA 510(k) clearance on 2016-05-10, under 510(k) number K152679.

Who is the listed applicant for Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak?

The FDA 510(k) record lists Bio-Rad Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak?

The FDA product code for Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak is PMN.

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