Clearance Summary
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT received FDA 510(k) clearance under submission number K080294, 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 2008-11-04.
- Submission: K080294
- Applicant / Sponsor: Astoria-Pacific, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1118
- Decision date: 2008-11-04
Classification & Regulation
This clearance is catalogued under FDA product code NAK and 21 CFR 862.1118, within the Clinical Chemistry review panel as a Class II device.