Clearance Summary
AMMONIA TEST received FDA 510(k) clearance under submission number K813366, sponsored by Wako Pure Chemical Industries, 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 1981-12-22.
- Submission: K813366
- Applicant / Sponsor: Wako Pure Chemical Industries, Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1065
- Decision date: 1981-12-22
Classification & Regulation
This clearance is catalogued under FDA product code JID and 21 CFR 862.1065, within the Clinical Chemistry review panel as a Class I device.