LCX
- Product code
- LCX
- Device name
- Kit, Test, Pregnancy, Hcg, Over The Counter
- Device class
- Class 2
- 21 CFR
- 21 CFR 862.1155
- Medical specialty
- Clinical Chemistry
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 16
- Summaries archived here
- 10 (direct download)
- 510(k) clearances (all years, FDA)
- 226 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (16)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K251040 | 2025-09-09 | Guangzhou Decheng Biotechnology Co., L… | MissLan® Early Detection Digital Pregnancy Test; Mis… | |
| K251053 | 2025-07-15 | Hangzhou AllTest Biotech Co., Ltd. | Shinetell PlusTM Digital Early Pregnancy Test | |
| K250117 | 2025-02-13 | Assure Tech., LLC | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rap… | |
| K242135 | 2025-01-31 | Nanjing Synthgene Medical Technology C… | Synthgene Home Test HCG Test Strip; Synthgene Home T… | FDA |
| K243573 | 2025-01-15 | Assure Tech., LLC | FaStep Early Pregnancy Rapid Test Strip; FaStep Earl… | |
| K241394 | 2024-12-20 | Andon Health Co, Ltd. | iHealth® Early Pregnancy Test; iHealth® Early Pregna… | |
| K240242 | 2024-10-11 | Anhui Deepblue Medical Technology Co.,… | HCG Home Use Pregnancy Test Strip (Colloidal Gold), … | |
| K241978 | 2024-08-13 | Hangzhou AllTest Biotech Co., Ltd. | Shinetell Digital Pregnancy Test | FDA |
| K240643 | 2024-06-21 | Guangzhou Decheng Biotechnology Co., L… | MissLan® Early Detection Pregnancy Test Strip; MissL… | |
| K232715 | 2024-05-31 | ACON Laboratories, Inc. | Distinct® Digital Pregnancy Test | — |
| K233624 | 2024-04-12 | Hangzhou Aichek Medical Technology Co.… | HCG One Step Pregnancy Test Strip OTC, HCG One Step … | |
| K234152 | 2024-04-05 | Aceso Laboratories, Inc. | ACESO Early Pregnancy Test | FDA |
| K233174 | 2024-02-05 | Assure Tech. (Hangzhou) Co, Ltd. | FaStep Pregnancy Rapid Test Strip; FaStep Pregnanc… | |
| K240025 | 2024-01-31 | Spd Swiss Precision Diagnostics GmbH | Clearblue® Early Detection Pregnancy Test | — |
| K232864 | 2024-01-26 | Nantong Egens Biotechnology Co., Ltd. | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Te… | FDA |
| K230741 | 2023-10-13 | Jiangsu Macro & Micro-Test Med-Tech Co… | Macro & Micro-Test HCG Pregnancy Test Midstream |
Official FDA classification page: LCX
Classification and pathway per current FDA publications. Data from openFDA (CC0).