Clearance Summary
Applied Biosystems Bacillus anthracis Detection Kit received FDA 510(k) clearance under submission number K183462, sponsored by Mriglobal. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2019-10-01.
- Submission: K183462
- Applicant / Sponsor: Mriglobal
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class:
- Decision date: 2019-10-01
Classification & Regulation
This clearance is catalogued under FDA product code QIF , within the Immunology review panel as a device.