Clearance Summary
APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS received FDA 510(k) clearance under submission number K061377, sponsored by Pointe Scientific, 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 2007-03-28.
- Submission: K061377
- Applicant / Sponsor: Pointe Scientific, Inc.,
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1475
- Decision date: 2007-03-28
Classification & Regulation
This clearance is catalogued under FDA product code MSJ and 21 CFR 862.1475, within the Clinical Chemistry review panel as a Class I device.