Clearance Summary
GLUCOSE-SL-C ASSAY, MODEL 257-30 received FDA 510(k) clearance under submission number K023739, 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 2003-01-17.
- Submission: K023739
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1345
- Decision date: 2003-01-17
Classification & Regulation
This clearance is catalogued under FDA product code CFR and 21 CFR 862.1345, within the Clinical Chemistry review panel as a Class II device.