510(k) K190705
K190705 is an FDA 510(k) premarket notification submitted by Wholepower Biotech Co., Ltd. for the device "WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream". The FDA issued a decision of Substantially Equivalent on Apr 15, 2019. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 15, 2019
- Date Received
- Mar 19, 2019
- 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
- 510(k)