Clearance Summary
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 received FDA 510(k) clearance under submission number K973108, 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 1998-03-02.
- Submission: K973108
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1635
- Decision date: 1998-03-02
Classification & Regulation
This clearance is catalogued under FDA product code CEK and 21 CFR 862.1635, within the Clinical Chemistry review panel as a Class II device.