Clearance Summary
KODAK AMERLITE CK-MB CONTROL SERA LAN.4413 received FDA 510(k) clearance under submission number K925880, sponsored by Eastman Kodak Company. 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 1993-02-05.
- Submission: K925880
- Applicant / Sponsor: Eastman Kodak Company
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1993-02-05
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.