Clearance Summary
REPLACEMENT REAGENTS FOR SMAC II SYSTEMS received FDA 510(k) clearance under submission number K852306, sponsored by Methodist Hospital of Memphis. 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 1985-08-02.
- Submission: K852306
- Applicant / Sponsor: Methodist Hospital of Memphis
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2150
- Decision date: 1985-08-02
Classification & Regulation
This clearance is catalogued under FDA product code JJC and 21 CFR 862.2150, within the Clinical Chemistry review panel as a Class I device.