510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ucp Biosciences, Inc.

Milpitas, CA, US

UCP BIOSCIENCES, INC. appears in FDA device records in Milpitas, CA. FDA records list 14 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
14
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 14 510(k) clearances for Ucp Biosciences, Inc. between 2005 and 2016. The busiest year on record is 2013, with 4. The most recent is 2016, with 1.

Clearances by year, as a table
510(k) clearance decisions for Ucp Biosciences, Inc., by decision year
YearClearances
20051
20061
20071
20091
20101
20111
20121
20134
20141
20151
20161
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K152908UCP COMPACT DRUG TESTSDKZSubstantially Equivalent
K151213UCP Drug Test Mini CupsDKZSubstantially Equivalent
K132812UCP MULTI-DRUG TEST KEY CUPSDKZSubstantially Equivalent
K131236UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIPLCXSubstantially Equivalent
K131811UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPSDKZSubstantially Equivalent
K130463UCP HOME DRUG SCREENING TEST; CARDS, CUPSDKZSubstantially Equivalent
K123863UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPSDKZSubstantially Equivalent
K122419UCP HOME DRUG SCREENING TEST CUPSDKZSubstantially Equivalent
K110515UCP DRUG SCREENING TEST CUPSDISSubstantially Equivalent
K091612UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST;DJGSubstantially Equivalent
K091588UCP HOME DRUG SCREENING TESTSDKZSubstantially Equivalent
K072062UCP MULTIPLE DRUG SCREEN TEST CUPSLFGSubstantially Equivalent
K061457UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTSLFGSubstantially Equivalent
K050540UCP RAPID DRUG SCREENING TESTSDKZSubstantially Equivalent

Registered establishments

FDA registered establishments for Ucp Biosciences, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30049872973004987297UCP BIOSCIENCES, INC.1900 Mccarthy Blvd Ste 204, Milpitas, CA 95035 US2026and 4 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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Data as of , FDA export datePage updated Source: openFDA, public domain