Clearance Summary
MUELLER HINTON AGAR W/OXACILLIN received FDA 510(k) clearance under submission number K941985, sponsored by Carr-Scarborough Microbiologicals, 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 1994-08-24.
- Submission: K941985
- Applicant / Sponsor: Carr-Scarborough Microbiologicals, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1700
- Decision date: 1994-08-24
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.