Clearance Summary
ACCESS MYOGLOBIN REAGENTS received FDA 510(k) clearance under submission number K951634, sponsored by Bio-Rad Laboratories, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1995-09-27.
- Submission: K951634
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5680
- Decision date: 1995-09-27
Classification & Regulation
This clearance is catalogued under FDA product code DDR and 21 CFR 866.5680, within the Immunology review panel as a Class II device.