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FDA 510(k)

RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS

K-Number: K003809 · 2001-04-20

ApplicantRapid Diagnostics, Inc.
Decision Date2001-04-20
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-04-20 under 510(k) number K003809. 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 RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS?

RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS is a medical device that received FDA 510(k) clearance on 2001-04-20. The listed applicant is Rapid Diagnostics, Inc.. The 510(k) number is K003809.

When did RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS receive FDA 510(k) clearance?

RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS received FDA 510(k) clearance on 2001-04-20, under 510(k) number K003809.

Who is the listed applicant for RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS?

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

What is the FDA product code for RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS?

The FDA product code for RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELS is DKZ.

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Other records listing Rapid Diagnostics, Inc. 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.

K033566MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062K020716RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)K981770RAPIDHCG PREGNANCY TEST

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

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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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