Clearance Summary
ACE MAGNESIUM REGENT received FDA 510(k) clearance under submission number K122302, sponsored by Alfa Wassermann Diagnostics Technologies, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2012-08-27.
- Submission: K122302
- Applicant / Sponsor: Alfa Wassermann Diagnostics Technologies, LLC
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1495
- Decision date: 2012-08-27
Classification & Regulation
This clearance is catalogued under FDA product code JGJ and 21 CFR 862.1495, within the Clinical Chemistry review panel as a Class I device.