MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream
FDA 510(k) clearance K240643 · decided 2024-06-21
Clearance details
- K-number
- K240643
- Device name
- MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test Midstream
- Applicant
- Guangzhou Decheng Biotechnology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-03-07
- Decision date
- 2024-06-21
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Guangzhou, 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 |
| Distinct® Digital Pregnancy Test (K232715) | ACON Laboratories, Inc. | 2024-05-31 |
| 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 (K233624) | Hangzhou Aichek Medical Technology Co., Ltd. | 2024-04-12 |
| 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.