Clearance Summary
SPOTCHECK NEONATAL GALT MICROPLATE REAGENT KIT received FDA 510(k) clearance under submission number K102643, sponsored by Astoria-Pacific, 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 2011-07-15.
- Submission: K102643
- Applicant / Sponsor: Astoria-Pacific, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1315
- Decision date: 2011-07-15
Classification & Regulation
This clearance is catalogued under FDA product code KQP and 21 CFR 862.1315, within the Clinical Chemistry review panel as a Class II device.