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FDA 510(k)

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay

K-Number: K191638 · 2020-03-12

ApplicantMedtest DX
Decision Date2020-03-12
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is a medical device manufactured by Medtest DX. It received FDA 510(k) clearance on 2020-03-12 under approval number K191638. 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 Pointe Scientific Cocaine Metabolite Enzyme Immunoassay?

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is a medical device that received FDA 510(k) clearance on 2020-03-12. It is manufactured by Medtest DX. The 510(k) number is K191638.

When was Pointe Scientific Cocaine Metabolite Enzyme Immunoassay approved by the FDA?

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay received FDA 510(k) clearance on 2020-03-12, under approval number K191638.

What company makes Pointe Scientific Cocaine Metabolite Enzyme Immunoassay?

Pointe Scientific Cocaine Metabolite Enzyme Immunoassay is manufactured by Medtest DX.

What is the FDA product code for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay?

The FDA product code for Pointe Scientific Cocaine Metabolite Enzyme Immunoassay 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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