Ucp Biosciences, Inc.: FDA clearances and approvals
Ucp Biosciences, Inc. has 14 FDA 510(k) clearances (first 2005, latest 2016), across 5 product codes in 2 review panels. Median 510(k) review time: 91 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 113 |
| 2013 | 4 | 56 |
| 2014 | 1 | 178 |
| 2015 | 1 | 107 |
| 2016 | 1 | 215 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 9 | 9 |
| LFG | Radioimmunoassay, Tricyclic Antidepressant Drugs | 2 | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 | 1 |
Review panels
Most recent Ucp Biosciences, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152908 | UCP COMPACT DRUG TESTS | DKZ | 2016-05-03 | 215 |
| K151213 | UCP Drug Test Mini Cups | DKZ | 2015-08-21 | 107 |
| K132812 | UCP MULTI-DRUG TEST KEY CUPS | DKZ | 2014-03-06 | 178 |
| K131236 | UCP PREGNANCY CASSETTE TEST, DIP/CARD STRIP, HOME PREGNANCY CASSETTE TEST, MIDSTREAM TEST AND DIP/CARD STRIP | LCX | 2013-11-07 | 190 |
| K131811 | UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS | DKZ | 2013-07-19 | 30 |
| K130463 | UCP HOME DRUG SCREENING TEST; CARDS, CUPS | DKZ | 2013-05-15 | 82 |
| K123863 | UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS | DKZ | 2013-01-09 | 26 |
| K122419 | UCP HOME DRUG SCREENING TEST CUPS | DKZ | 2012-11-30 | 113 |
| K110515 | UCP DRUG SCREENING TEST CUPS | DIS | 2011-04-20 | 56 |
| K091612 | UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST; | DJG | 2010-02-24 | 266 |
4 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Ucp Biosciences, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Ucp Biosciences, Inc. have?
Ucp Biosciences, Inc. has 14 FDA 510(k) clearances (first 2005, latest 2016), across 5 product codes in 2 review panels.
How long does FDA take to clear Ucp Biosciences, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Ucp Biosciences, Inc.'s cleared 510(k)s is 91 days.
What devices does Ucp Biosciences, Inc. make?
Its most frequent FDA product codes are DKZ (Enzyme Immunoassay, Amphetamine, 9); LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs, 2); DIS (Enzyme Immunoassay, Barbiturate, 1).
Has Ucp Biosciences, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Ucp Biosciences, Inc. Related entities may recall under other names.
Next steps
- See all 14 Ucp Biosciences, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DKZ, Ucp Biosciences, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.