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FDA 510(k)

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators

K-Number: K161714 · 2016-10-14

ApplicantImmunalysis Corporation
Decision Date2016-10-14
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Immunalysis Corporation. The 510(k) number is K161714.

When was Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators approved by the FDA?

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

What company makes Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators?

Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators is manufactured by Immunalysis Corporation.

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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Official Source

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

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