Atlas FDA

LabPro Data Management System

FDA 510(k) clearance K201405 · decided 2020-08-30

Clearance details

K-number
K201405
Device name
LabPro Data Management System
Applicant
Beckman Coulter, Inc.
Decision
Substantially Equivalent
Date received
2020-05-28
Decision date
2020-08-30
Days to decision
94 days
Clearance type
Traditional
Product code
LON
Device class
2
Regulation number
866.1645
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
West Sacramento, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
REF # D23352, MicroScan LabPro V5.03 Panel Update 11 (US), Electronic installed on the fol recall (Z-2888-2026)Beckman Coulter Inc.2026-08-05
REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit (US) on the following instrum recall (Z-2889-2026)Beckman Coulter Inc.2026-08-05

PMA approvals by this applicant

RecordFirmDate
Access AFP (on DxI 9000 Analyzer) (P980041/S051)Beckman Coulter, Inc.2025-11-03
Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015)Beckman Coulter, Inc.2025-10-17
Access Hybritech p2PSA (P090026/S032)Beckman Coulter, Inc.2025-06-16
Access Hybritech free PSA (P970038/S046)Beckman Coulter, Inc.2025-05-15
Access Hybritech PSA (P850048/S060)Beckman Coulter, Inc.2024-09-04
Access Hybritech PSA reagent pack (P850048/S059)Beckman Coulter, Inc.2023-05-25
Access AFP Reagents on the Access Immunoassay Systems (P980041/S050)Beckman Coulter, Inc.2022-12-16
Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057)Beckman Coulter, Inc.2022-12-16