Clearance Summary
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH received FDA 510(k) clearance under submission number K060452, sponsored by Neo-Genesis. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2007-03-13.
- Submission: K060452
- Applicant / Sponsor: Neo-Genesis
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1395
- Decision date: 2007-03-13
Classification & Regulation
This clearance is catalogued under FDA product code JLX and 21 CFR 862.1395, within the Clinical Chemistry review panel as a Class I device.