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FDA 510(k)

MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062

K-Number: K033566 · 2004-05-17

ApplicantRapid Diagnostics, Inc.
Decision Date2004-05-17
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 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 2004-05-17 under 510(k) number K033566. 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 MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062?

MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 is a medical device that received FDA 510(k) clearance on 2004-05-17. The listed applicant is Rapid Diagnostics, Inc.. The 510(k) number is K033566.

When did MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 receive FDA 510(k) clearance?

MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 received FDA 510(k) clearance on 2004-05-17, under 510(k) number K033566.

Who is the listed applicant for MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062?

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 MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062?

The FDA product code for MICROMEDIC DRUGS OF ABUSE PANEL TEST (9), CATALOG NUMBER 07RD-7062 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.

K020716RAPID OPIATES TEST STRIP II, RAPID OPIATES TEST CARD II AND DOA MULTIPLE DRUG TEST CARDS (UP TO SIX TESTS)K003809RAPID DRUGS OF ABUSE SINGLE AND MULTIPLE TEST PANELSK981770RAPIDHCG 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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