510(k) K162698
K162698 is an FDA 510(k) premarket notification submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. for the device "MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay Analyzer". The FDA issued a decision of Substantially Equivalent on July 14, 2017. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. 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
- July 14, 2017
- Date Received
- September 27, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Thyroid-Stimulating Hormone
- Device Class
- Class II
- Regulation Number
- 862.1690
- Review Panel
- CH
- Submission Type