LCX
- 产品代码
- LCX
- 器械名称
- Kit, Test, Pregnancy, Hcg, Over The Counter
- 管理类别
- 第 2 类（Class II）
- 21 CFR 条款
- 21 CFR 862.1155
- FDA 专业组
- Clinical Chemistry
- 上市路径
- 需提交 510(k) 上市前通告
- 标记
- 可走第三方审查
- 该代码近三年的 510(k)
- 226 件
该代码近三年的 510(k)（16 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 | 摘要 |
|---|---|---|---|---|
| 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 |
FDA 官方分类页： LCX
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA（CC0 公有领域），不构成注册策略建议。