510(k) K183097
K183097 is an FDA 510(k) premarket notification submitted by Weihai Kangzhou Biotechnology Engineering Co., Ltd. for the device "Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream". The FDA issued a decision of Substantially Equivalent on Jan 10, 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
- Jan 10, 2019
- Date Received
- Nov 7, 2018
- 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)