510(k) K201405 ยท LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
LabPro Data Management System
| Applicant | Beckman Coulter, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Aug 30, 2020 |
| Received | May 28, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K201405
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 5, 2026 | Beckman Coulter Inc. REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the following instruments:
- B1018-280 MicroScan autoSCAN-4 Instrument
- B1018-283 MicroScan WalkAway-40 plus Instr Open, Classified |
LON | None listed |
| Aug 5, 2026 | Beckman Coulter Inc. REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instruments:
- B1018-280 MicroScan autoSCAN-4 Instrument
- B1018-283 MicroScan WalkAway-40 plus Instrument
- B1018-2 Open, Classified |
LON | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.