Clearance Summary
Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30 received FDA 510(k) clearance under submission number K974000, 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 1997-11-04.
- Submission: K974000
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1360
- Decision date: 1997-11-04
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.