Clearance Summary
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT received FDA 510(k) clearance under submission number K113438, sponsored by Alfa Wassermann Diagnostic Technologies, Inc.. 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 2012-06-01.
- Submission: K113438
- Applicant / Sponsor: Alfa Wassermann Diagnostic Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1415
- Decision date: 2012-06-01
Classification & Regulation
This clearance is catalogued under FDA product code JMO and 21 CFR 862.1415, within the Clinical Chemistry review panel as a Class I device.