Data / Medical devices / China / Prometheus Bio Inc.
Prometheus Bio Inc.: FDA-registered device maker in Hangzhou Zhejiang, China, 12 510(k) clearances
Prometheus Bio Inc. is registered with the FDA (registration 3011559327) in Hangzhou Zhejiang, China. It lists 12 device types. The FDA files 12 510(k) clearances under its listings, the newest dated August 21, 2015. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011559327
- Address
- No.3, 8th Street, Qiantang New Area, Hangzhou,Zhejiang,310018,CHNIA, Hangzhou Zhejiang, China, 310018
- Owner or operator
- Prometheus Bio Inc. (10055881)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- October 15, 2017
- Registered through
- 2026
- Brand names listed
- Number One Flat Multi-Panel Drug Test Cup, Number One Multi-Panel Drug Test Cup, UCP Compact Drug Tests, UCP Drug Screening Test Cups, UCP Home Drug Screening Test Cups, UCP Home Drug Screening Tests, UCP Mini Drug Test Cups, UCP Multi-Drug Test Key Cups and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2015 | K151213 | UCP Drug Test Mini Cups | DKZ | Substantially Equivalent | Ucp Biosciences, Inc. | accessdata.fda.gov |
| March 6, 2014 | K132812 | UCP MULTI-DRUG TEST KEY CUPS | DKZ | Substantially Equivalent | Ucp Biosciences, Inc. | accessdata.fda.gov |
| July 19, 2013 | K131811 | UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS | DKZ | Substantially Equivalent | Ucp Biosciences, Inc. | accessdata.fda.gov |
| May 15, 2013 | K130463 | UCP HOME DRUG SCREENING TEST; CARDS, CUPS | DKZ | Substantially Equivalent | Ucp Biosciences, Inc. | accessdata.fda.gov |
| January 9, 2013 | K123863 | UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS | DKZ | Substantially Equivalent | Ucp Biosciences, Inc. | accessdata.fda.gov |
| November 30, 2012 | K122419 | UCP HOME DRUG SCREENING TEST CUPS | DKZ | Substantially Equivalent | Ucp Biosciences, Inc. | accessdata.fda.gov |
| April 20, 2011 | K110515 | UCP DRUG SCREENING TEST CUPS | DIS | Substantially Equivalent | Ucp Biosciences, Inc. | accessdata.fda.gov |
| February 24, 2010 | K091612 | UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; | DJG | Substantially Equivalent | Ucp Biosciences, Inc. | accessdata.fda.gov |
| September 4, 2009 | K091588 | UCP HOME DRUG SCREENING TESTS | DKZ | Substantially Equivalent | Ucp Biosciences, Inc. | accessdata.fda.gov |
| September 20, 2007 | K072062 | UCP MULTIPLE DRUG SCREEN TEST CUPS | LFG | Substantially Equivalent | Ucp Biosciences, Inc. | accessdata.fda.gov |
| August 21, 2006 | K061457 | UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS | LFG | Substantially Equivalent | Ucp Biosciences, Inc. | accessdata.fda.gov |
| April 29, 2005 | K050540 | UCP RAPID DRUG SCREENING TESTS | DKZ | Substantially Equivalent | Ucp Biosciences, Inc. | accessdata.fda.gov |
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Updated August 21, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.