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FDA 510(k)

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)

Número K: K163570 · 2017-08-15

RequerenteCarolina Liquid Chemistries Corporation
Data da decisão2017-08-15
Código do produtoDIO
Comité consultivoTX
DecisãoSubstantially Equivalent

Resumo do dispositivo

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Liquid Chemistries Corporation. It received FDA 510(k) clearance on 2017-08-15 under 510(k) number K163570. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)?

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) is a medical device that received FDA 510(k) clearance on 2017-08-15. The listed applicant is Carolina Liquid Chemistries Corporation. The 510(k) number is K163570.

When did Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) receive FDA 510(k) clearance?

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) received FDA 510(k) clearance on 2017-08-15, under 510(k) number K163570.

Who is the listed applicant for Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)?

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

What is the FDA product code for Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)?

The FDA product code for Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM) is DIO.

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Dispositivos Relacionados (Código: DIO)

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