510(k) K221493
K221493 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "MicroScan Prompt Inoculation System-D". The FDA issued a decision of Substantially Equivalent on April 5, 2023. The device falls under product code LIE (Reagent/Device, Inoculum Calibration), a Class II device regulated under 21 CFR 866.1640. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 2023
- Date Received
- May 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Reagent/Device, Inoculum Calibration
- Device Class
- Class II
- Regulation Number
- 866.1640
- Review Panel
- MI
- Submission Type