Clearance Summary
CK-MB ASSAY, CATALOGUE NUMBER 317-10 received FDA 510(k) clearance under submission number K942773, 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 1994-08-24.
- Submission: K942773
- Applicant / Sponsor: Diagnostic Chemicals , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 1994-08-24
Classification & Regulation
This clearance is catalogued under FDA product code CGS and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.