Clearance Summary
CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A received FDA 510(k) clearance under submission number K032951, sponsored by Chrono-Log Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2004-04-02.
- Submission: K032951
- Applicant / Sponsor: Chrono-Log Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5700
- Decision date: 2004-04-02
Classification & Regulation
This clearance is catalogued under FDA product code JOZ and 21 CFR 864.5700, within the Hematology review panel as a Class II device.