510(k) K201405
K201405 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "LabPro Data Management System". The FDA issued a decision of Substantially Equivalent on Aug 30, 2020. The device falls under product code LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation), a Class II device regulated under 21 CFR 866.1645. Beckman Coulter, Inc. has 277 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 30, 2020
- Date Received
- May 28, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Device Class
- Class II
- Regulation Number
- 866.1645
- Review Panel
- MI
- Submission Type
- 510(k)