Clearance Summary
ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13K received FDA 510(k) clearance under submission number K010844, 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 2001-09-21.
- Submission: K010844
- Applicant / Sponsor: Astoria-Pacific, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1118
- Decision date: 2001-09-21
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.