Clearance Summary
ALKALINE PHOSPHATASE LIQUID REAGENT-KINETIC, MODELS A504-150 AND A504-500H received FDA 510(k) clearance under submission number K000067, sponsored by Teco Diagnostics. The device was reviewed via the Special premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2000-01-20.
- Submission: K000067
- Applicant / Sponsor: Teco Diagnostics
- Clearance pathway: Special
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1050
- Decision date: 2000-01-20
Classification & Regulation
This clearance is catalogued under FDA product code CJE and 21 CFR 862.1050, within the Clinical Chemistry review panel as a Class II device.