510(k) K191499
K191499 is an FDA 510(k) premarket notification submitted by Shenzhen New Industries Biomedical Engineering Co., Ltd. for the device "MAGLUMI 2000 25-OH Vitamin D". The FDA issued a decision of Substantially Equivalent on August 1, 2019. The device falls under product code MRG (System, Test, Vitamin D), a Class II device regulated under 21 CFR 862.1825. 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
- August 1, 2019
- Date Received
- June 6, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Vitamin D
- Device Class
- Class II
- Regulation Number
- 862.1825
- Review Panel
- CH
- Submission Type