510(k) K192123
K192123 is an FDA 510(k) premarket notification submitted by Qingdao Hightop Biotech Co., Ltd. for the device "HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream". The FDA issued a decision of Substantially Equivalent on September 5, 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. Qingdao Hightop Biotech Co., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 2019
- Date Received
- August 6, 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