K240025
- 510(k) number
- K240025
- Device name
- Clearblue® Early Detection Pregnancy Test
- Applicant
- Spd Swiss Precision Diagnostics GmbH CH
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2024-01-31
- Date received
- 2024-01-03
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Clinical Chemistry
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K240025
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.