FDA 510(k)

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

Número K: K161646 · 2016-11-04

Data da decisão2016-11-04

Código do produtoCGN

Comité consultivoCH

DecisãoSubstantially Equivalent

Resumo do dispositivo

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories. It received FDA 510(k) clearance on 2016-11-04 under 510(k) number K161646. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set?

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is a medical device that received FDA 510(k) clearance on 2016-11-04. The listed applicant is Diazyme Laboratories. The 510(k) number is K161646.

When did Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set receive FDA 510(k) clearance?

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set received FDA 510(k) clearance on 2016-11-04, under 510(k) number K161646.

Who is the listed applicant for Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set?

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

What is the FDA product code for Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set?

The FDA product code for Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is CGN.

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Outros registros que listam Diazyme Laboratories como candidato(a)

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Fonte oficial

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