Clearance Summary
PHOSPHORUS-SL ASSAY, CATALOGUE NUMBER 117-10, 117-30 received FDA 510(k) clearance under submission number K974858, 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 1998-01-30.
- Submission: K974858
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1580
- Decision date: 1998-01-30
Classification & Regulation
This clearance is catalogued under FDA product code CEO and 21 CFR 862.1580, within the Clinical Chemistry review panel as a Class I device.