| 2025-09-09 |
K251040 |
Guangzhou Decheng Biotechnology Co., Ltd.
|
MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test |
| 2025-07-15 |
K251053 |
Hangzhou AllTest Biotech Co., Ltd.
|
Shinetell PlusTM Digital Early Pregnancy Test |
| 2025-02-13 |
K250117 |
Assure Tech., LLC
|
FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette |
| 2025-01-31 |
K242135 |
Nanjing Synthgene Medical Technology Co., Ltd.
|
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream |
| 2025-01-15 |
K243573 |
Assure Tech., LLC
|
FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream |
| 2024-12-20 |
K241394 |
Andon Health Co, Ltd.
|
iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip |
| 2024-10-11 |
K240242 |
Anhui Deepblue Medical Technology Co., Ltd.
|
HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) |
| 2024-08-13 |
K241978 |
Hangzhou AllTest Biotech Co., Ltd.
|
Shinetell Digital Pregnancy Test |
| 2024-06-21 |
K240643 |
Guangzhou Decheng Biotechnology Co., Ltd.
|
MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream |
| 2024-05-31 |
K232715 |
ACON Laboratories, Inc.
|
Distinct® Digital Pregnancy Test |
| 2024-04-12 |
K233624 |
Hangzhou Aichek Medical Technology Co., Ltd.
|
HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx |
| 2024-04-05 |
K234152 |
Aceso Laboratories, Inc.
|
ACESO Early Pregnancy Test |
| 2024-02-05 |
K233174 |
Assure Tech. (Hangzhou) Co, Ltd.
|
FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream |
| 2024-01-31 |
K240025 |
Spd Swiss Precision Diagnostics GmbH
|
Clearblue® Early Detection Pregnancy Test |
| 2024-01-26 |
K232864 |
Nantong Egens Biotechnology Co., Ltd.
|
EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II |
| 2023-10-13 |
K230741 |
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
|
Macro & Micro-Test HCG Pregnancy Test Midstream |
| 2023-02-28 |
K230038 |
Guangzhou Decheng Biotechnology Co., Ltd.
|
MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) |
| 2022-11-30 |
K222305 |
Guangzhou Decheng Biotechnology Co., Ltd.
|
MissLan Digital Pregnancy Rapid Test |
| 2022-09-21 |
K213379 |
Spd Swiss Precision Diagnostics GmbH
|
Clearblue ® Early Pregnancy Test |
| 2022-06-30 |
K212418 |
Healstone Biotech, Inc.
|
hCG One Step Pregnancy Test |
| 2022-04-05 |
K213808 |
Co-Innovation Biotech Co., Ltd.
|
Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream |
| 2022-03-10 |
K210341 |
Spd Swiss Precision Diagnostics GmbH
|
One Step Pregnancy Test |
| 2022-02-18 |
K212447 |
Hangzhou Sejoy Electronics & Instruments Co., Ltd.
|
SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream |
| 2021-08-13 |
K200913 |
Spd Swiss Precision Diagnostics GmbH
|
Clearblue® Early Digital Pregnancy Test |
| 2021-08-04 |
K203246 |
Atlas Link Technology Co., Ltd.
|
Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) |