Clearance Summary
ACCESS TOTAL BHCG ASSAY received FDA 510(k) clearance under submission number K926198, sponsored by Bio-Rad Laboratories, 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 1993-02-08.
- Submission: K926198
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 1993-02-08
Classification & Regulation
This clearance is catalogued under FDA product code JHI and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.