Clearance Summary
TARGET(TM) CK-MB received FDA 510(k) clearance under submission number K890295, sponsored by V-Tech, 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 1989-08-15.
- Submission: K890295
- Applicant / Sponsor: V-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1215
- Decision date: 1989-08-15
Classification & Regulation
This clearance is catalogued under FDA product code JHY and 21 CFR 862.1215, within the Clinical Chemistry review panel as a Class II device.