K232715
- 510(k) number
- K232715
- Device name
- Distinct® Digital Pregnancy Test
- Applicant
- ACON Laboratories, Inc. CA · US
- Product code
- LCX — Kit, Test, Pregnancy, Hcg, Over The Counter
- Decision date
- 2024-05-31
- Date received
- 2023-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- 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: K232715
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.