510(k) K233174
K233174 is an FDA 510(k) premarket notification submitted by Assure Tech. (Hangzhou) Co, Ltd. for the device "FaStep Pregnancy Rapid Test Strip; FaStep Pregnancy Rapid Test Midstream". The FDA issued a decision of Substantially Equivalent on February 5, 2024. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Assure Tech. (Hangzhou) Co, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2024
- Date Received
- September 28, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Test, Pregnancy, Hcg, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type