Clearance Summary
ATAC 8000 RANDOM ACCESS CHEMISTRY SYSTEM received FDA 510(k) clearance under submission number K945271, sponsored by Bio-Chem Laboratory Systems, 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 1995-04-20.
- Submission: K945271
- Applicant / Sponsor: Bio-Chem Laboratory Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2160
- Decision date: 1995-04-20
Classification & Regulation
This clearance is catalogued under FDA product code JJE and 21 CFR 862.2160, within the Clinical Chemistry review panel as a Class I device.