510(k) K162399
K162399 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "Atellica CH Magnesium (Mg)". The FDA issued a decision of Substantially Equivalent on January 19, 2017. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 19, 2017
- Date Received
- August 26, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Photometric Method, Magnesium
- Device Class
- Class I
- Regulation Number
- 862.1495
- Review Panel
- CH
- Submission Type