Clearance Summary
MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025 received FDA 510(k) clearance under submission number K092919, sponsored by Siemens Healthcare Diagnostics. The device was reviewed via the Special premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 2009-10-23.
- Submission: K092919
- Applicant / Sponsor: Siemens Healthcare Diagnostics
- Clearance pathway: Special
- Review panel: Microbiology
- Device class: Class II
- Regulation citation: 21 CFR 866.1645
- Decision date: 2009-10-23
Classification & Regulation
This clearance is catalogued under FDA product code LON and 21 CFR 866.1645, within the Microbiology review panel as a Class II device.