Chemtrue(R) HCG Pregnancy Urine Midstream Test
FDA 510(k) K131931 · Chemtron Biotech, Inc.
510(k) numberK131931
Submission
- Device name
- Chemtrue(R) HCG Pregnancy Urine Midstream Test
- Applicant
- Chemtron Biotech, Inc.
San Diego, CA, US - Received
- June 27, 2013
- Decision date
- July 26, 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 |
|---|---|---|
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…DJG · Traditional | 12/20/2023SE |
| K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…DJG · Traditional | 04/18/2016SE |
| K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000DJG · Traditional | 04/17/2015SE |
| K142580 | Chemtrue Multi-Panel DOA DIP Card TestsDKZ · Special | 12/01/2014SE |
| K142396 | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette TestsDJG · Traditional | 10/09/2014SE |
| K123844 | Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo…JHI · Traditional | 05/30/2013SE |
| K123080 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette TestsJXM · Traditional | 11/29/2012SE |
| K121339 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette TestsDKZ · Traditional | 05/17/2012SE |
| K111322 | Chemtrue Single/Multi-Panel Drug Screen Cassette/DipcardJXM · Traditional | 09/14/2011SE |
| K102203 | Chemtrue Single / Multi Drug Screen Cassette / Dip Card TestsDKZ · Traditional | 01/20/2011SE |
Questions and answers
When was Chemtrue(R) HCG Pregnancy Urine Midstream Test cleared by the FDA?
Chemtrue(R) HCG Pregnancy Urine Midstream Test (K131931) received a 510(k) decision of Substantially Equivalent on July 26, 2013, 29 days after the submission was received.
What is the product code of K131931?
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.