Clearance Summary
ATAC 6000 CHEMISTRY ANALYZER received FDA 510(k) clearance under submission number K902689, sponsored by Bio-Chem Laboratories. 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 1990-07-10.
- Submission: K902689
- Applicant / Sponsor: Bio-Chem Laboratories
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2160
- Decision date: 1990-07-10
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.