Clearance Summary
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL received FDA 510(k) clearance under submission number K911347, sponsored by Bio-Rad. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1991-06-10.
- Submission: K911347
- Applicant / Sponsor: Bio-Rad
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7415
- Decision date: 1991-06-10
Classification & Regulation
This clearance is catalogued under FDA product code JCM and 21 CFR 864.7415, within the Hematology review panel as a Class II device.