Clearance Summary
CK-NAC REAGENT(CREATINE KINASE/N-ACETYL CYSTEINE) received FDA 510(k) clearance under submission number K864359, sponsored by Trace Scientific , 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 1987-02-06.
- Submission: K864359
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 1987-02-06
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.