Clearance Summary
CK-NAC 2-VIAL REAGENT W/SUBSTRATE START received FDA 510(k) clearance under submission number K891470, 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 1989-05-09.
- Submission: K891470
- Applicant / Sponsor: Trace Scientific , Ltd.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 1989-05-09
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.