Clearance Summary
SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT received FDA 510(k) clearance under submission number K121101, 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 2013-06-20.
- Submission: K121101
- Applicant / Sponsor: Astoria-Pacific, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1310
- Decision date: 2013-06-20
Classification & Regulation
This clearance is catalogued under FDA product code JIA and 21 CFR 862.1310, within the Clinical Chemistry review panel as a Class I device.