K221493 is an FDA 510(k) clearance for the MicroScan Prompt Inoculation System-D. This device is classified as a Reagent/device, Inoculum Calibration (Class II - Special Controls, product code LIE).
Submitted by Beckman Coulter, Inc. (West Sacramento, US). The FDA issued a Cleared decision on April 5, 2023, 317 days after receiving the submission on May 23, 2022.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K221493 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2022 |
| Decision Date | April 05, 2023 |
| Days to Decision | 317 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LIE — Reagent/device, Inoculum Calibration |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |