FDA 510(k)

BioPlex 2200 25-OH Vitamin D Kit

Número K: K180577 · 2018-06-22

Data da decisão2018-06-22

Código do produtoMRG

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

BioPlex 2200 25-OH Vitamin D Kit 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 2018-06-22 under 510(k) number K180577. The device is classified under product code MRG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BioPlex 2200 25-OH Vitamin D Kit?

BioPlex 2200 25-OH Vitamin D Kit is a medical device that received FDA 510(k) clearance on 2018-06-22. The listed applicant is Bio-Rad Laboratories. The 510(k) number is K180577.

When did BioPlex 2200 25-OH Vitamin D Kit receive FDA 510(k) clearance?

BioPlex 2200 25-OH Vitamin D Kit received FDA 510(k) clearance on 2018-06-22, under 510(k) number K180577.

Who is the listed applicant for BioPlex 2200 25-OH Vitamin D Kit?

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 BioPlex 2200 25-OH Vitamin D Kit?

The FDA product code for BioPlex 2200 25-OH Vitamin D Kit is MRG.

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Dispositivos Relacionados (Código: MRG)

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