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FDA 510(k)

UCP HOME DRUG SCREENING TEST; CARDS, CUPS

K-Number: K130463 · 2013-05-15

ApplicantUcp Biosciences, Inc.
Decision Date2013-05-15
Product CodeDKZ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

UCP HOME DRUG SCREENING TEST; CARDS, CUPS is the device name listed in this FDA 510(k) record. The listed applicant is Ucp Biosciences, Inc.. It received FDA 510(k) clearance on 2013-05-15 under 510(k) number K130463. 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 UCP HOME DRUG SCREENING TEST; CARDS, CUPS?

UCP HOME DRUG SCREENING TEST; CARDS, CUPS is a medical device that received FDA 510(k) clearance on 2013-05-15. The listed applicant is Ucp Biosciences, Inc.. The 510(k) number is K130463.

When did UCP HOME DRUG SCREENING TEST; CARDS, CUPS receive FDA 510(k) clearance?

UCP HOME DRUG SCREENING TEST; CARDS, CUPS received FDA 510(k) clearance on 2013-05-15, under 510(k) number K130463.

Who is the listed applicant for UCP HOME DRUG SCREENING TEST; CARDS, CUPS?

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

What is the FDA product code for UCP HOME DRUG SCREENING TEST; CARDS, CUPS?

The FDA product code for UCP HOME DRUG SCREENING TEST; CARDS, CUPS is DKZ.

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Other records listing Ucp Biosciences, 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.

K152908UCP COMPACT DRUG TESTSK131236UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIPK131811UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPSK123863UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPSK122419UCP HOME DRUG SCREENING TEST CUPSK110515UCP DRUG SCREENING TEST CUPS

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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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