Clearance Summary
ACCESS ULTRASENSITIVE INSULIN ASSAY received FDA 510(k) clearance under submission number K953084, 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 1995-09-25.
- Submission: K953084
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1405
- Decision date: 1995-09-25
Classification & Regulation
This clearance is catalogued under FDA product code CFP and 21 CFR 862.1405, within the Clinical Chemistry review panel as a Class I device.