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
FDA 510(k) clearance K233624 · decided 2024-04-12
Clearance details
- K-number
- K233624
- Device name
- 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
- Applicant
- Hangzhou Aichek Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-11-13
- Decision date
- 2024-04-12
- Days to decision
- 151 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital Pregnancy Test (K251040) | Guangzhou Decheng Biotechnology Co., Ltd. | 2025-09-09 |
| Shinetell PlusTM Digital Early Pregnancy Test (K251053) | Hangzhou AllTest Biotech Co., Ltd. | 2025-07-15 |
| FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette (K250117) | Assure Tech., LLC | 2025-02-13 |
| Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream (K242135) | Nanjing Synthgene Medical Technology Co., Ltd. | 2025-01-31 |
| FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette; FaStep Early Pregnancy Rapid Test Midstream (K243573) | Assure Tech., LLC | 2025-01-15 |
| iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip (K241394) | Andon Health Co, Ltd. | 2024-12-20 |
| HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) (K240242) | Anhui Deepblue Medical Technology Co., Ltd. | 2024-10-11 |
| Shinetell Digital Pregnancy Test (K241978) | Hangzhou AllTest Biotech Co., Ltd. | 2024-08-13 |
| MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream (K240643) | Guangzhou Decheng Biotechnology Co., Ltd. | 2024-06-21 |
| Distinct® Digital Pregnancy Test (K232715) | ACON Laboratories, Inc. | 2024-05-31 |
| ACESO Early Pregnancy Test (K234152) | Aceso Laboratories, Inc. | 2024-04-05 |
| FaStep™ Pregnancy Rapid Test Strip; FaStep™ Pregnancy Rapid Test Midstream (K233174) | Assure Tech. (Hangzhou) Co, Ltd. | 2024-02-05 |
Recalls involving this device
No recalls on record reference this clearance.