Clearance Summary
MCDB 302 MEDIUM, M2021 received FDA 510(k) clearance under submission number K851862, sponsored by Sigma Cell Culture Reagents. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1985-05-20.
- Submission: K851862
- Applicant / Sponsor: Sigma Cell Culture Reagents
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2220
- Decision date: 1985-05-20
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.