Clearance Summary
CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ received FDA 510(k) clearance under submission number K850907, sponsored by Cala Diagnostics. 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 1985-06-25.
- Submission: K850907
- Applicant / Sponsor: Cala Diagnostics
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1985-06-25
Classification & Regulation
This clearance is catalogued under FDA product code JJT and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.