Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test, Midstream Test and Dip/Card Strip
FDA 510(k) K131236 · Ucp Biosciences, Inc.
510(k) numberK131236
Submission
- Device name
- Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test, Midstream Test and Dip/Card Strip
- Applicant
- Ucp Biosciences, Inc.
San Jose, CA, US - Received
- May 1, 2013
- Decision date
- November 7, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LCX – Kit, Test, Pregnancy, Hcg, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251040 | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy…LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 09/09/2025SE |
| K251053 | Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 07/15/2025SE |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX · Traditional | Assure Tech., LLC | 02/13/2025SE |
| K242135 | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene…LCX · Traditional | Nanjing Synthgene Medical Technology Co., Ltd. | 01/31/2025SE |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional | Assure Tech., LLC | 01/15/2025SE |
| K241394 | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test StripLCX · Traditional | Andon Health Co, Ltd. | 12/20/2024SE |
| K240242 | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette…LCX · Traditional | Anhui Deepblue Medical Technology Co., Ltd. | 10/11/2024SE |
| K241978 | Shinetell Digital Pregnancy TestLCX · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 08/13/2024SE |
| K240643 | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test…LCX · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 06/21/2024SE |
| K232715 | Distinct® Digital Pregnancy TestLCX · Traditional | ACON Laboratories, Inc. | 05/31/2024SE |
More from ACON Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K152908 | Ucp Compact Drug TestsDKZ · Traditional | 05/03/2016SE |
| K151213 | UCP Drug Test Mini CupsDKZ · Special | 08/21/2015SE |
| K132812 | Ucp Multi-Drug Test Key CupsDKZ · Traditional | 03/06/2014SE |
| K131811 | Ucp Compact Drug Test Cards, Ucp Compact Drug Test CupsDKZ · Special | 07/19/2013SE |
| K130463 | Ucp Home Drug Screening Test; Cards, CupsDKZ · Traditional | 05/15/2013SE |
| K123863 | Ucp Compact Drug Test Cards, Ucp Compact Drug Test CupsDKZ · Special | 01/09/2013SE |
| K122419 | Ucp Home Drug Screening Test CupsDKZ · Traditional | 11/30/2012SE |
| K110515 | Ucp Drug Screening Test CupsDIS · Special | 04/20/2011SE |
| K091612 | Ucp Rapid Drug Screening Buprenorphine, Amp 300, Mamp 500, Coc 150 Test;DJG · Traditional | 02/24/2010SE |
| K091588 | Ucp Home Drug Screening TestsDKZ · Traditional | 09/04/2009SE |
Questions and answers
When was Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test, Midstream Test and Dip/Card Strip cleared by the FDA?
Ucp Pregnancy Cassette Test, Dip/Card Strip, Home Pregnancy Cassette Test, Midstream Test and Dip/Card Strip (K131236) received a 510(k) decision of Substantially Equivalent on November 7, 2013, 190 days after the submission was received.
What is the product code of K131236?
The FDA product code is LCX – Kit, Test, Pregnancy, Hcg, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1155.