Clearance Summary
AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 received FDA 510(k) clearance under submission number K100715, sponsored by Aalto Scientific, Ltd.. 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 2010-12-23.
- Submission: K100715
- Applicant / Sponsor: Aalto Scientific, Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2010-12-23
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.