K234152
- 510(k) number
- K234152
- Device name
- ACESO Early Pregnancy Test
- Applicant
- Aceso Laboratories, Inc. CA · US
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2024-04-05
- Date received
- 2023-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K234152.pdf
Official FDA record: K234152
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.