Clearance Summary
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK received FDA 510(k) clearance under submission number K042336, sponsored by Bio-Rad Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 2004-10-14.
- Submission: K042336
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8625
- Decision date: 2004-10-14
Classification & Regulation
This clearance is catalogued under FDA product code JPK and 21 CFR 864.8625, within the Hematology review panel as a Class II device.