Clearance Summary
MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES received FDA 510(k) clearance under submission number K845014, sponsored by Sigma Chemical Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1985-02-27.
- Submission: K845014
- Applicant / Sponsor: Sigma Chemical Co.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2220
- Decision date: 1985-02-27
Classification & Regulation
This clearance is catalogued under FDA product code KIT and 21 CFR 864.2220, within the Hematology review panel as a Class I device.