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FDA 510(k)

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

K-Number: K213211 · 2022-01-27

ApplicantCarolina Liquid Chemistries Corp.
Decision Date2022-01-27
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System is a medical device manufactured by Carolina Liquid Chemistries Corp.. It received FDA 510(k) clearance on 2022-01-27 under approval number K213211. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Carolina Liquid Chemistries Corp.. The 510(k) number is K213211.

When was Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System approved by the FDA?

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

What company makes 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 manufactured by Carolina Liquid Chemistries Corp..

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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