K241978
- 510(k) number
- K241978
- Device name
- Shinetell Digital Pregnancy Test
- Applicant
- Hangzhou AllTest Biotech Co., Ltd. CN
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2024-08-13
- Date received
- 2024-07-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
510(k) Summary (official FDA PDF): K241978.pdf
Official FDA record: K241978
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.