Clearance Summary
ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT received FDA 510(k) clearance under submission number K123322, sponsored by Alfa Wassermann Diagnostics Technologies, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2013-05-21.
- Submission: K123322
- Applicant / Sponsor: Alfa Wassermann Diagnostics Technologies, LLC
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1770
- Decision date: 2013-05-21
Classification & Regulation
This clearance is catalogued under FDA product code CDN and 21 CFR 862.1770, within the Clinical Chemistry review panel as a Class II device.