510(k) K192547
K192547 is an FDA 510(k) premarket notification submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. for the device "MAGLUMI 2000 HCG/ß-HCG". The FDA issued a decision of Substantially Equivalent on January 17, 2020. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Shenzhen New Industries Biomedical Engineering Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2020
- Date Received
- September 17, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Human Chorionic Gonadotropin
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type