Clearance Summary
PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT received FDA 510(k) clearance under submission number K964756, sponsored by Wano-Tech Corp.. 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 1997-04-23.
- Submission: K964756
- Applicant / Sponsor: Wano-Tech Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1020
- Decision date: 1997-04-23
Classification & Regulation
This clearance is catalogued under FDA product code JFH and 21 CFR 862.1020, within the Clinical Chemistry review panel as a Class II device.