Clearance Summary
FASTPACK TOTAL PSA METHOD VERIFICATION KIT received FDA 510(k) clearance under submission number K062957, sponsored by Qualigen, Inc.. 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 2007-04-02.
- Submission: K062957
- Applicant / Sponsor: Qualigen, Inc.
- Clearance pathway: Abbreviated
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 2007-04-02
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.