FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream— 510(k) K233174
Substantially EquivalentAssure Tech. (Hangzhou) Co, Ltd.
FDA 510(k) clearance K233174 for FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream, Substantially Equivalent on 2024-02-05. Applicant: Assure Tech. (Hangzhou) Co, Ltd.. Device class: 2.
Clearance details
- Applicant
- Assure Tech. (Hangzhou) Co, Ltd.
- Product code
- Code LCX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.