LabPro Data Management System— 510(k) K201405
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K201405 for LabPro Data Management System, Substantially Equivalent on 2020-08-30. Applicant: Beckman Coulter, Inc.. Device class: 2.
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Code LON
- Device class
- Class 2
- Regulation
- 21 CFR 866.1645
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Sacramento, CA, US
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More clearances from Beckman Coulter, Inc.
view allAdverse events under product code LON
product code LON- Malfunction
- 2,383
- Total
- 2,383
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K201405
K-number listed on FDA's recall record- Z-2888-2026 — 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 Instrument - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument
- Z-2889-2026 — 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 - B1018-284 MicroScan WalkAway-96 plus Instrument - B1018-440 DxM-1040 MicroScan WalkAway Instrument - B1018-496 DxM-1096 MicroScan WalkAway Instrument
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K201405.
Data sourced from openFDA. This site is unofficial and independent of the FDA.