Pregnagen 1-STEP Pregnancy Test
FDA 510(k) K925189 · Biogenex Laboratories
510(k) numberK925189
Submission
- Device name
- Pregnagen 1-STEP Pregnancy Test
- Applicant
- Biogenex Laboratories
San Diego, CA, US - Received
- October 13, 1992
- Decision date
- January 6, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K012960 | Biogenex Monoclonal Anti-Progesterone ReceptorMXZ · Traditional | 03/08/2002SE |
| K013148 | Biogenex Monoclonal Anti-Estrogen Receptor(Clone ER88)MYA · Traditional | 02/28/2002SE |
| K902208 | Modified OvugenCEP · Traditional | 07/17/1990SE |
| K884880 | Pregnagen(Tm)JHI · Traditional | 01/13/1989SE |
| K882002 | Pregnagen(Tm)JHI · Traditional | 09/09/1988SE |
| K873534 | Ovugen SuretestCEP · Traditional | 11/23/1987SE |
| K831221 | Riagen B-Hcg Ria KitJHI · Traditional | 06/02/1983SE |
| K821657 | Riagen B-Hcg RiaJHI · Traditional | 07/13/1982SE |
| K821234 | Riagen B-Hcg RiaJHI · Traditional | 05/21/1982SE |
| K820724 | Fluorogen Pap FiaJFH · Traditional | 04/14/1982SE |
Questions and answers
When was Pregnagen 1-STEP Pregnancy Test cleared by the FDA?
Pregnagen 1-STEP Pregnancy Test (K925189) received a 510(k) decision of Substantially Equivalent on January 6, 1993, 85 days after the submission was received.
What is the product code of K925189?
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.