Clearance Summary
ACCESS PROLACTIN ASSAY (MODIFICATION) received FDA 510(k) clearance under submission number K954680, 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 1995-10-20.
- Submission: K954680
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1625
- Decision date: 1995-10-20
Classification & Regulation
This clearance is catalogued under FDA product code CFT and 21 CFR 862.1625, within the Clinical Chemistry review panel as a Class I device.