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FDA 510(k)

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

Número K: K161714 · 2016-10-14

RequerenteImmunalysis Corporation
Data da decisão2016-10-14
Código do produtoDIS
Comité consultivoTX
DecisãoSubstantially Equivalent

Resumo do dispositivo

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is the device name listed in this FDA 510(k) record. The listed applicant is Immunalysis Corporation. It received FDA 510(k) clearance on 2016-10-14 under 510(k) number K161714. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is a medical device that received FDA 510(k) clearance on 2016-10-14. The listed applicant is Immunalysis Corporation. The 510(k) number is K161714.

When did Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators receive FDA 510(k) clearance?

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators received FDA 510(k) clearance on 2016-10-14, under 510(k) number K161714.

Who is the listed applicant for Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

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

What is the FDA product code for Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

The FDA product code for Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is DIS.

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