Clearance Summary
CHEM-PRO 1000 CLINICAL CHEMISTRY-ANALYSIS SYS received FDA 510(k) clearance under submission number K855091, sponsored by Sen Tech Medical Corp.. 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 1986-03-14.
- Submission: K855091
- Applicant / Sponsor: Sen Tech Medical Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1770
- Decision date: 1986-03-14
Classification & Regulation
This clearance is catalogued under FDA product code CDS and 21 CFR 862.1770, within the Clinical Chemistry review panel as a Class II device.