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FDA 510(k)

QuickScreen Pro Multi Drug Screening Test, Model 9395Z

K-Number: K181945 · 2018-10-18

ApplicantPhamatech, Inc.
Decision Date2018-10-18
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

QuickScreen Pro Multi Drug Screening Test, Model 9395Z is a medical device manufactured by Phamatech, Inc.. It received FDA 510(k) clearance on 2018-10-18 under approval number K181945. 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 QuickScreen Pro Multi Drug Screening Test, Model 9395Z?

QuickScreen Pro Multi Drug Screening Test, Model 9395Z is a medical device that received FDA 510(k) clearance on 2018-10-18. It is manufactured by Phamatech, Inc.. The 510(k) number is K181945.

When was QuickScreen Pro Multi Drug Screening Test, Model 9395Z approved by the FDA?

QuickScreen Pro Multi Drug Screening Test, Model 9395Z received FDA 510(k) clearance on 2018-10-18, under approval number K181945.

What company makes QuickScreen Pro Multi Drug Screening Test, Model 9395Z?

QuickScreen Pro Multi Drug Screening Test, Model 9395Z is manufactured by Phamatech, Inc..

What is the FDA product code for QuickScreen Pro Multi Drug Screening Test, Model 9395Z?

The FDA product code for QuickScreen Pro Multi Drug Screening Test, Model 9395Z is DKZ.

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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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