Clearance Summary
ELECSYS CALCHECK CA 125II received FDA 510(k) clearance under submission number K981278, sponsored by Roche Diagnostics GmbH. 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 1998-04-23.
- Submission: K981278
- Applicant / Sponsor: Roche Diagnostics GmbH
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1998-04-23
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.