Clearance Summary
MUELLER HINTON AGAR & MUELLER HINTON AGAR W/5% SHE received FDA 510(k) clearance under submission number K851589, sponsored by Preferred Micro-Media. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 1985-04-30.
- Submission: K851589
- Applicant / Sponsor: Preferred Micro-Media
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1700
- Decision date: 1985-04-30
Classification & Regulation
This clearance is catalogued under FDA product code JTZ and 21 CFR 866.1700, within the Microbiology review panel as a Class II device.