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FDA 510(k)

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

Número K: K213211 · 2022-01-27

RequerenteCarolina Liquid Chemistries Corp.
Data da decisão2022-01-27
Código do produtoDIO
Comité consultivoTX
DecisãoSubstantially Equivalent

Resumo do dispositivo

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is the device name listed in this FDA 510(k) record. The listed applicant is Carolina Liquid Chemistries Corp.. It received FDA 510(k) clearance on 2022-01-27 under 510(k) number K213211. 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 Enzyme Immunoassay (COCM) Test System?

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is a medical device that received FDA 510(k) clearance on 2022-01-27. The listed applicant is Carolina Liquid Chemistries Corp.. The 510(k) number is K213211.

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

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System received FDA 510(k) clearance on 2022-01-27, under 510(k) number K213211.

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

The FDA 510(k) record lists Carolina Liquid Chemistries Corp. 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 Enzyme Immunoassay (COCM) Test System?

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

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