Clearance Summary
QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS received FDA 510(k) clearance under submission number K042446, 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 2004-11-02.
- Submission: K042446
- Applicant / Sponsor: Bio-Rad Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2004-11-02
Classification & Regulation
This clearance is catalogued under FDA product code JJW and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.