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FDA 510(k)

UCP DRUG SCREENING TEST CUPS

K-Number: K110515 · 2011-04-20

ApplicantUcp Biosciences, Inc.
Decision Date2011-04-20
Product CodeDIS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

UCP DRUG SCREENING TEST 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 2011-04-20 under 510(k) number K110515. The device is classified under product code DIS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UCP DRUG SCREENING TEST CUPS?

UCP DRUG SCREENING TEST CUPS is a medical device that received FDA 510(k) clearance on 2011-04-20. The listed applicant is Ucp Biosciences, Inc.. The 510(k) number is K110515.

When did UCP DRUG SCREENING TEST CUPS receive FDA 510(k) clearance?

UCP DRUG SCREENING TEST CUPS received FDA 510(k) clearance on 2011-04-20, under 510(k) number K110515.

Who is the listed applicant for UCP DRUG SCREENING TEST 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 DRUG SCREENING TEST CUPS?

The FDA product code for UCP DRUG SCREENING TEST CUPS is DIS.

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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 CUPSK130463UCP HOME DRUG SCREENING TEST; CARDS, CUPSK123863UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPSK122419UCP HOME DRUG SCREENING TEST CUPS

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Related Devices (Code: DIS)

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.

K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis CorporationK092268RANDOX BARITURATES ASSAYRandox Laboratories, Ltd.K070098QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SCPhamatech, Inc.K070009AT HOME DRUG TEST MODELS, 9308T AND 9308XPhamatech, Inc.K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSOrtho-Clinical DiagnosticsK050024ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYSGuangzhou Wondfo Biotech Co., Ltd.

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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