510(k) K182423
K182423 is an FDA 510(k) premarket notification submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. for the device "MAGLUMI 2000 FT4". The FDA issued a decision of Substantially Equivalent on October 4, 2018. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. 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
- October 4, 2018
- Date Received
- September 6, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Free Thyroxine
- Device Class
- Class II
- Regulation Number
- 862.1695
- Review Panel
- CH
- Submission Type