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FDA 510(k)

FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)

K-Number: K020869 · 2002-06-11

ApplicantWorldwide Medical Corp.
Decision Date2002-06-11
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) is the device name listed in this FDA 510(k) record. The listed applicant is Worldwide Medical Corp.. It received FDA 510(k) clearance on 2002-06-11 under 510(k) number K020869. 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 FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)?

FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) is a medical device that received FDA 510(k) clearance on 2002-06-11. The listed applicant is Worldwide Medical Corp.. The 510(k) number is K020869.

When did FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) receive FDA 510(k) clearance?

FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) received FDA 510(k) clearance on 2002-06-11, under 510(k) number K020869.

Who is the listed applicant for FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)?

The FDA 510(k) record lists Worldwide Medical Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY)?

The FDA product code for FIRST CHECK HOME DRUG TEST FOR MDMA (ECSTASY) 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.

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Other records listing Worldwide Medical Corp. as applicant

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.

K993852FIRST CHECK HOME DRUG TEST PANEL 4K994139FIRST CHECK HOME DRUG TEST PANEL 2K993663FIRST CHECK HOME DRUG TEST (THC)K994138FIRST CHECK HOME DRUG TEST PANEL 3

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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