510(k) K111915
K111915 is an FDA 510(k) premarket notification submitted by Sekisui Diagnostics P.E.I., Inc. for the device "MAGNESIUM ASSAY". The FDA issued a decision of Substantially Equivalent on Dec 2, 2011. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Sekisui Diagnostics P.E.I., Inc. has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 2, 2011
- Date Received
- Jul 6, 2011
- 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
- 510(k)