Clearance Summary
LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30 received FDA 510(k) clearance under submission number K974859, 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 1998-01-22.
- Submission: K974859
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1440
- Decision date: 1998-01-22
Classification & Regulation
This clearance is catalogued under FDA product code CFJ and 21 CFR 862.1440, within the Clinical Chemistry review panel as a Class II device.