FDA 510(k)

UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST;

K-Number: K091612 · 2010-02-24

Decision Date2010-02-24

Product CodeDJG

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; 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 2010-02-24 under 510(k) number K091612. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST;?

UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; is a medical device that received FDA 510(k) clearance on 2010-02-24. The listed applicant is Ucp Biosciences, Inc.. The 510(k) number is K091612.

When did UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; receive FDA 510(k) clearance?

UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; received FDA 510(k) clearance on 2010-02-24, under 510(k) number K091612.

Who is the listed applicant for UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST;?

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 RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST;?

The FDA product code for UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; is DJG.

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Other records listing Ucp Biosciences, Inc. as applicant

K152908UCP COMPACT DRUG TESTS K131236UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP K131811UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS K130463UCP HOME DRUG SCREENING TEST; CARDS, CUPS K123863UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS K122419UCP HOME DRUG SCREENING TEST CUPS

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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.