Clearance Summary
MUELLER-HINTON AGAR PLATE received FDA 510(k) clearance under submission number K834421, sponsored by Otisville Biotech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 1984-02-03.
- Submission: K834421
- Applicant / Sponsor: Otisville Biotech, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1700
- Decision date: 1984-02-03
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.