LCX — Kit, Test, Pregnancy, Hcg, Over The Counter Class II
FDA product code LCX covers "Kit, Test, Pregnancy, Hcg, Over The Counter", a Class II medical device regulated under 21 CFR 862.1155. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LCX
- Device Class
- Class II
- Regulation Number
- 862.1155
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251040 | guangzhou decheng biotechnology co | MissLan® Early Detection Digital Pregnancy Test; MissLan® Early Result Digital P | September 9, 2025 |
| K251053 | hangzhou alltest biotech co | Shinetell PlusTM Digital Early Pregnancy Test | July 15, 2025 |
| K250117 | assure tech | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test Cassette | February 13, 2025 |
| K242135 | nanjing synthgene medical technology co | Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synth | January 31, 2025 |
| K243573 | assure tech | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Casse | January 15, 2025 |
| K241394 | andon health co | iHealth® Early Pregnancy Test; iHealth® Early Pregnancy Test Strip | December 20, 2024 |
| K240242 | anhui deepblue medical technology co | HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test | October 11, 2024 |
| K241978 | hangzhou alltest biotech co | Shinetell Digital Pregnancy Test | August 13, 2024 |
| K240643 | guangzhou decheng biotechnology co | MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnanc | June 21, 2024 |
| K232715 | acon laboratories | Distinct® Digital Pregnancy Test | May 31, 2024 |
| K233624 | hangzhou aichek medical technology co | HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG | April 12, 2024 |
| K234152 | aceso laboratories | ACESO Early Pregnancy Test | April 5, 2024 |
| K233174 | assure tech. (hangzhou) co | FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream | February 5, 2024 |
| K240025 | spd swiss precision diagnostics | Clearblue® Early Detection Pregnancy Test | January 31, 2024 |
| K232864 | nantong egens biotechnology co | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | January 26, 2024 |
| K230741 | jiangsu macro and micro-test med-tech co | Macro & Micro-Test HCG Pregnancy Test Midstream | October 13, 2023 |
| K230038 | guangzhou decheng biotechnology co | MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) | February 28, 2023 |
| K222305 | guangzhou decheng biotechnology co | MissLan Digital Pregnancy Rapid Test | November 30, 2022 |
| K213379 | spd swiss precision diagnostics | Clearblue ® Early Pregnancy Test | September 21, 2022 |
| K212418 | healstone biotech | hCG One Step Pregnancy Test | June 30, 2022 |