Clearance Summary
AHLSTROM GRADE 226 SPECIMEN COLLECTION PAPER received FDA 510(k) clearance under submission number K062932, sponsored by Ahlstrom Mount Holly Springs, LLC. 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 2007-10-19.
- Submission: K062932
- Applicant / Sponsor: Ahlstrom Mount Holly Springs, LLC
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1675
- Decision date: 2007-10-19
Classification & Regulation
This clearance is catalogued under FDA product code JKA and 21 CFR 862.1675, within the Clinical Chemistry review panel as a Class II device.