Clearance Summary
C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) received FDA 510(k) clearance under submission number K982442, sponsored by Care Wise Medical Products Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1998-08-25.
- Submission: K982442
- Applicant / Sponsor: Care Wise Medical Products Corp.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class I
- Regulation citation: 21 CFR 892.1320
- Decision date: 1998-08-25
Classification & Regulation
This clearance is catalogued under FDA product code IZD and 21 CFR 892.1320, within the Radiology review panel as a Class I device.