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FDA 510(k)

ACCU NEWS Drug Screening Test Card/Urine Cup

K-Number: K152590 · 2016-04-15

ApplicantCoretests, Inc.
Decision Date2016-04-15
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ACCU NEWS Drug Screening Test Card/Urine Cup is a medical device manufactured by Coretests, Inc.. It received FDA 510(k) clearance on 2016-04-15 under approval number K152590. The device is classified under product code DKZ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCU NEWS Drug Screening Test Card/Urine Cup?

ACCU NEWS Drug Screening Test Card/Urine Cup is a medical device that received FDA 510(k) clearance on 2016-04-15. It is manufactured by Coretests, Inc.. The 510(k) number is K152590.

When was ACCU NEWS Drug Screening Test Card/Urine Cup approved by the FDA?

ACCU NEWS Drug Screening Test Card/Urine Cup received FDA 510(k) clearance on 2016-04-15, under approval number K152590.

What company makes ACCU NEWS Drug Screening Test Card/Urine Cup?

ACCU NEWS Drug Screening Test Card/Urine Cup is manufactured by Coretests, Inc..

What is the FDA product code for ACCU NEWS Drug Screening Test Card/Urine Cup?

The FDA product code for ACCU NEWS Drug Screening Test Card/Urine Cup is DKZ.

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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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