Clearance Summary
MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS received FDA 510(k) clearance under submission number K013423, sponsored by Dade Microscan, 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 2001-12-12.
- Submission: K013423
- Applicant / Sponsor: Dade Microscan, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1640
- Decision date: 2001-12-12
Classification & Regulation
This clearance is catalogued under FDA product code JWY and 21 CFR 866.1640, within the Microbiology review panel as a Class II device.