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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 the device name listed in this FDA 510(k) record. The listed applicant is Phamatech, Inc.. It received FDA 510(k) clearance on 2018-10-18 under 510(k) 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. The listed applicant is Phamatech, Inc.. The 510(k) number is K181945.

When did QuickScreen Pro Multi Drug Screening Test, Model 9395Z receive FDA 510(k) clearance?

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

Who is the listed applicant for QuickScreen Pro Multi Drug Screening Test, Model 9395Z?

The FDA 510(k) record lists Phamatech, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06968845A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary FibrosisRECRUITINGNCT06643715Research of the Application of Pancreatic Cancer Screening Artificial Intelligence Model "PANDAPro"ACTIVE_NOT_RECRUITING

Related Devices (Code: DKZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240670DRI Ecstasy Plus AssayMicrogenics CorporationK233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas MedicalK182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.

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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