Clearance Summary
URIC ACID CATALOGE# 220-93/94/97 received FDA 510(k) clearance under submission number K955496, sponsored by Diagnostic Chemicals , 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 1996-02-23.
- Submission: K955496
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1775
- Decision date: 1996-02-23
Classification & Regulation
This clearance is catalogued under FDA product code KNK and 21 CFR 862.1775, within the Clinical Chemistry review panel as a Class I device.