Clearance Summary
MUELLER HINTON AGAR WITH 5% SHEEP BLOOD received FDA 510(k) clearance under submission number K780958, sponsored by Pittsburgh Micro-Media, 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 1978-10-24.
- Submission: K780958
- Applicant / Sponsor: Pittsburgh Micro-Media, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1700
- Decision date: 1978-10-24
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.