510(k) K131811
- Device
- UCP COMPACT DRUG TEST CARDS, UCP COMPACT DRUG TEST CUPS
- Applicant
- UCP BIOSCIENCES, INC.
- 510(k) number
- K131811
- Product code
- DKZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-07-19
- Date received
- 2013-06-19
- Regulation
- 862.3100
- Classification name
- Enzyme Immunoassay, Amphetamine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- NANCY CHEN
- Address
- 1445 Koll Cir., Suite 111 San Jose CA US 95112 95112
FDA Registration Numbers#
- 1063851
- 3003795116
- 3036649420
- 3043127647
- 3005641941
- 3004987297
- 3009585529
- 3023296261
- 1050155
- 2090110
- 2432235
- 9610529
- 3030413233
- 1832216
- 3010220539
- 3008852306
- 3010852191
- 3030648160
- 3008416529
- 3008517993
- 3012073813
- 3005984081
- 3007838093
- 2029372
- 2027969
- 2000007960
- 1319681
- 3000308930
- 3002806944
- 3023322455
- 2020952
- 3009963993
- 3006048451
- 2087033
- 8043323
- 3009414546
- 3007606081
- 3005333358
- 2060833
- 3013077867
- 3005345870
- 3010939897
- 3004493545
- 3011559327
- 3010825766
- 3003917514
- 2031229
- 3016610313
- 2030633
- 3009212837
- 3010800486
- 3012725363
- 3013982035
- 3013684380
- 3011522054
- 2050012
- 2032364
- 3007126977
- 3010934853
- 3017904598
- 2250051
- 1649661
- 1036362
- 2517506
- 3008054239
- 3002642396
- 3008987086
- 3004175381
- 3009238284
- 2050010
- 3031697086
- 3003610499
- 3027519599
- 1910144
- 3006198300
- 2246703
- 3005360469
- 2030861
- 3031823359
- 3005174594
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DKZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240670 | DRI Ecstasy Plus Assay | Microgenics Corporation | 2024-10-30 |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx | Hangzhou AllTest Biotech Co., Ltd. | 2023-12-13 |
| K231137 | Xenta Drug Screen Cup, Xenta Drug Screen Dipcard | Xenta Biomedical Science Co., Ltd. | 2023-05-19 |
| K200363 | Quidel Triage® TOX Drug Screen, 94600 | Quidel Cardiovascular, Inc. | 2020-03-11 |
| K191099 | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel | Atlas Medical | 2019-10-03 |
| K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterPro | Quidel Cardiovascular, Inc. | 2019-06-19 |
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) | Hangzhou AllTest Biotech Co., Ltd. | 2019-03-27 |
| K180879 | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use | Shanghai Venture Bio-Tech Co., Ltd. | 2018-12-14 |
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395Z | Phamatech, Inc. | 2018-10-18 |
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) | Alfa Scientific Designs, Inc. | 2018-02-23 |
| K161251 | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests | Hangzhou Clongene Biotech Co., Ltd. | 2016-08-30 |
| K152122 | Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) | Alfa Scientific Designs, Inc. | 2016-06-24 |
| K152908 | UCP COMPACT DRUG TESTS | Ucp Biosciences, Inc. | 2016-05-03 |
| K152590 | ACCU NEWS Drug Screening Test Card/Urine Cup | Coretests, Inc. | 2016-04-15 |
| K153465 | AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) | Assure Tech. (Hangzhou) Co, Ltd. | 2016-03-31 |
FDA Review#
Decision Summary