Clearance Summary
Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05 received FDA 510(k) clearance under submission number K945800, 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 1995-06-09.
- Submission: K945800
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1360
- Decision date: 1995-06-09
Classification & Regulation
This clearance is catalogued under FDA product code JQB and 21 CFR 862.1360, within the Clinical Chemistry review panel as a Class I device.