The following data is part of a premarket notification filed by Beckman Coulter Inc. with the FDA for Labpro Data Management System.
| Device ID | K201405 |
| 510k Number | K201405 |
| Device Name: | LabPro Data Management System |
| Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Applicant | Beckman Coulter Inc. 1584 Enterprise Blvd West Sacramento, CA 95691 |
| Contact | Christina Thomas |
| Correspondent | Christina Thomas Beckman Coulter Inc. 1584 Enterprise Blvd West Sacramento, CA 95691 |
| Product Code | LON |
| CFR Regulation Number | 866.1645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-28 |
| Decision Date | 2020-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590738884 | K201405 | 000 |
| 15099590702779 | K201405 | 000 |
| 15099590702724 | K201405 | 000 |
| 15099590702717 | K201405 | 000 |
| 15099590772741 | K201405 | 000 |