Clearance Summary
CREATINE KINASE (CK) REAGENT SET received FDA 510(k) clearance under submission number K881237, sponsored by Tech-Neal Scientific, Inc.. 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 1988-04-28.
- Submission: K881237
- Applicant / Sponsor: Tech-Neal Scientific, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 1988-04-28
Classification & Regulation
This clearance is catalogued under FDA product code JHX and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.