510(k) K150022
K150022 is an FDA 510(k) premarket notification submitted by Guangzhou Wondfo Biotech Co., Ltd. for the device "Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One Step HCG Urine Pregnancy Test Cassette, Wondfo One Step HCG Urine Pregnancy Test Midstream". The FDA issued a decision of Substantially Equivalent on August 7, 2015. The device falls under product code LCX (Kit, Test, Pregnancy, Hcg, Over The Counter), a Class II device regulated under 21 CFR 862.1155. Guangzhou Wondfo Biotech Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 2015
- Date Received
- January 6, 2015
- 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